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FDA 510(k)

SURGICAL DRAPE PACK

K-Number: K864899 · 1987-01-20

ApplicantWebster Enterprises, Inc.
Decision Date1987-01-20
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRAPE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Webster Enterprises, Inc.. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K864899. 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 SURGICAL DRAPE PACK?

SURGICAL DRAPE PACK is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is Webster Enterprises, Inc.. The 510(k) number is K864899.

When did SURGICAL DRAPE PACK receive FDA 510(k) clearance?

SURGICAL DRAPE PACK received FDA 510(k) clearance on 1987-01-20, under 510(k) number K864899.

Who is the listed applicant for SURGICAL DRAPE PACK?

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

What is the FDA product code for SURGICAL DRAPE PACK?

The FDA product code for SURGICAL DRAPE PACK 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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