Biosp. Total Ossicular Replace. Prosthe.

FDA 510(k) K771725 · Xomed, Inc.

Substantially Equivalent

510(k) numberK771725

Submission

Device name
Biosp. Total Ossicular Replace. Prosthe.
Applicant
Xomed, Inc.
Arnold, MO, US
Received
September 13, 1977
Decision date
September 26, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FEX – Instrument, Catheter, Punch
Device class
Class I (low risk)
Regulation
21 CFR 876.5090
Specialty
Gastroenterology, Urology

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Questions and answers

When was Biosp. Total Ossicular Replace. Prosthe. cleared by the FDA?

Biosp. Total Ossicular Replace. Prosthe. (K771725) received a 510(k) decision of Substantially Equivalent on September 26, 1977, 13 days after the submission was received.

What is the product code of K771725?

The FDA product code is FEX – Instrument, Catheter, Punch, a Class I (low risk) device regulated under 21 CFR 876.5090.