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FDA 510(k)

CONTAMINATION CONTAINMENT DRAPE

K-Number: K954212 · 1995-10-23

ApplicantEngineering Controls For Medicine
Decision Date1995-10-23
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTAMINATION CONTAINMENT DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Engineering Controls For Medicine. It received FDA 510(k) clearance on 1995-10-23 under 510(k) number K954212. 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 CONTAMINATION CONTAINMENT DRAPE?

CONTAMINATION CONTAINMENT DRAPE is a medical device that received FDA 510(k) clearance on 1995-10-23. The listed applicant is Engineering Controls For Medicine. The 510(k) number is K954212.

When did CONTAMINATION CONTAINMENT DRAPE receive FDA 510(k) clearance?

CONTAMINATION CONTAINMENT DRAPE received FDA 510(k) clearance on 1995-10-23, under 510(k) number K954212.

Who is the listed applicant for CONTAMINATION CONTAINMENT DRAPE?

The FDA 510(k) record lists Engineering Controls For Medicine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTAMINATION CONTAINMENT DRAPE?

The FDA product code for CONTAMINATION CONTAINMENT DRAPE is KKX.

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Related Devices (Code: KKX)

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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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