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FDA 510(k)

TIELLE* HYDROPOLYMER DRESSING

K-Number: K946245 · 1995-04-11

ApplicantJohnson & Johnson International
Decision Date1995-04-11
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TIELLE* HYDROPOLYMER DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson International. It received FDA 510(k) clearance on 1995-04-11 under 510(k) number K946245. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIELLE* HYDROPOLYMER DRESSING?

TIELLE* HYDROPOLYMER DRESSING is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is Johnson & Johnson International. The 510(k) number is K946245.

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

TIELLE* HYDROPOLYMER DRESSING received FDA 510(k) clearance on 1995-04-11, under 510(k) number K946245.

Who is the listed applicant for TIELLE* HYDROPOLYMER DRESSING?

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

What is the FDA product code for TIELLE* HYDROPOLYMER DRESSING?

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

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Other records listing Johnson & Johnson International 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.

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Related Devices (Code: KMF)

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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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