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FDA 510(k)

DISPOSABLE EMISSIONS BARRIER LASER DRAPE

K-Number: K903346 · 1990-12-05

ApplicantWave-Form Systems, Inc.
Decision Date1990-12-05
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE EMISSIONS BARRIER LASER DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Wave-Form Systems, Inc.. It received FDA 510(k) clearance on 1990-12-05 under 510(k) number K903346. 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 DISPOSABLE EMISSIONS BARRIER LASER DRAPE?

DISPOSABLE EMISSIONS BARRIER LASER DRAPE is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is Wave-Form Systems, Inc.. The 510(k) number is K903346.

When did DISPOSABLE EMISSIONS BARRIER LASER DRAPE receive FDA 510(k) clearance?

DISPOSABLE EMISSIONS BARRIER LASER DRAPE received FDA 510(k) clearance on 1990-12-05, under 510(k) number K903346.

Who is the listed applicant for DISPOSABLE EMISSIONS BARRIER LASER DRAPE?

The FDA 510(k) record lists Wave-Form Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE EMISSIONS BARRIER LASER DRAPE?

The FDA product code for DISPOSABLE EMISSIONS BARRIER LASER 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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