FDA 510(k), K051996, DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30

FDA 510(k), K051996, DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30

Regular price $415.84 USD
Regular price Sale price $415.84 USD
Sale Sold out

510(K) Number: K051996
Device Name: DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30
Manufacturer: TIM PHIPPS
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 07/25/2005
Decision Date: 08/18/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

Total pages: 294
Fully redacted pages: 143 (≤ 50 words or fully redacted)
Content pages: 151

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

View full details