FDA 510(k) K973865, BIRTCHER UV LAMP, by Medfaxx, Inc.

FDA 510(k) K973865, BIRTCHER UV LAMP, by Medfaxx, Inc.

Regular price $314.26 USD
Regular price Sale price $314.26 USD
Sale Sold out

Device Classification Name: Lamp, Uvc, (For Treating Skin And Wounds)
510(k) Number: K973865
Device Name: BIRTCHER UV LAMP
Applicant: Medfaxx, Inc.
Regulation Number: 878.4630
Classification Product Code: MXG
Date Received: 10/06/1997
Decision Date: 02/26/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 83
Fully redacted pages: 6
Content pages: 77

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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