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FDA 510(k)

LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING

K-Number: K900945 · 1990-05-09

ApplicantPalex Medical, Inc.
Decision Date1990-05-09
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Palex Medical, Inc.. It received FDA 510(k) clearance on 1990-05-09 under 510(k) number K900945. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING?

LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING is a medical device that received FDA 510(k) clearance on 1990-05-09. The listed applicant is Palex Medical, Inc.. The 510(k) number is K900945.

When did LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING receive FDA 510(k) clearance?

LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING received FDA 510(k) clearance on 1990-05-09, under 510(k) number K900945.

Who is the listed applicant for LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING?

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

What is the FDA product code for LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING?

The FDA product code for LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING is KKX.

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Related Devices (Code: KKX)

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

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

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