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FDA 510(k)

P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)

K-Number: K971189 · 1997-07-17

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1997-07-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1997-07-17 under 510(k) number K971189. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)?

P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) is a medical device that received FDA 510(k) clearance on 1997-07-17. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K971189.

When did P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) receive FDA 510(k) clearance?

P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) received FDA 510(k) clearance on 1997-07-17, under 510(k) number K971189.

Who is the listed applicant for P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)?

The FDA product code for P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) is JWH.

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Related Devices (Code: JWH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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