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FDA 510(k)

FIBRACOL COLLAGEN-ALGINATE DRESSING

K-Number: K925548 · 1993-07-13

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1993-07-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FIBRACOL COLLAGEN-ALGINATE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1993-07-13 under 510(k) number K925548. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRACOL COLLAGEN-ALGINATE DRESSING?

FIBRACOL COLLAGEN-ALGINATE DRESSING is a medical device that received FDA 510(k) clearance on 1993-07-13. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K925548.

When did FIBRACOL COLLAGEN-ALGINATE DRESSING receive FDA 510(k) clearance?

FIBRACOL COLLAGEN-ALGINATE DRESSING received FDA 510(k) clearance on 1993-07-13, under 510(k) number K925548.

Who is the listed applicant for FIBRACOL COLLAGEN-ALGINATE DRESSING?

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

What is the FDA product code for FIBRACOL COLLAGEN-ALGINATE DRESSING?

The FDA product code for FIBRACOL COLLAGEN-ALGINATE DRESSING is FMF.

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Other records listing Johnson & Johnson Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLEK982641ADVANCED NIBP MODULEK983362NU-GEL * WOUND DRESSINGK982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEK974080CRITIKON SOFT BLOOD PRESSURE CUFFK980493I.V. CATHETER SYSTEM

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Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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