FDA 510(k), K953763, GLADIATOR ANTISHOCK PANTS

FDA 510(k), K953763, GLADIATOR ANTISHOCK PANTS

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510(K) Number: K953763
Device Name: GLADIATOR ANTISHOCK PANTS
Manufacturer: JOBST INSTITUTE, INC.
Device Classification Name: Trousers, Anti-Shock
Regulation Number: 870.5800
Classification Product Code: LHX
Date Received: 08/11/1995
Decision Date: 11/28/1995
Regulation Medical Specialty: Cardiovascular

129 pages (23 of 152 pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

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