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FDA 510(k)

TIELLE HYDROPOLYMER FOAM DRESSING

K-Number: K964016 · 1996-12-31

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1996-12-31
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

TIELLE HYDROPOLYMER FOAM 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 1996-12-31 under 510(k) number K964016. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TIELLE HYDROPOLYMER FOAM DRESSING?

TIELLE HYDROPOLYMER FOAM DRESSING is a medical device that received FDA 510(k) clearance on 1996-12-31. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K964016.

When did TIELLE HYDROPOLYMER FOAM DRESSING receive FDA 510(k) clearance?

TIELLE HYDROPOLYMER FOAM DRESSING received FDA 510(k) clearance on 1996-12-31, under 510(k) number K964016.

Who is the listed applicant for TIELLE HYDROPOLYMER FOAM 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 TIELLE HYDROPOLYMER FOAM DRESSING?

The FDA product code for TIELLE HYDROPOLYMER FOAM DRESSING is KMF.

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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: KMF)

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.

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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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