FDA 510(k)

OR/CS WRAP

K-Number: K810646 · 1981-03-20

ApplicantAmerican Threshold Industries, Inc.

Decision Date1981-03-20

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

OR/CS WRAP is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1981-03-20 under 510(k) number K810646. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OR/CS WRAP?

OR/CS WRAP is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K810646.

When did OR/CS WRAP receive FDA 510(k) clearance?

OR/CS WRAP received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810646.

Who is the listed applicant for OR/CS WRAP?

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

What is the FDA product code for OR/CS WRAP?

The FDA product code for OR/CS WRAP is FRG.

Other records listing American Threshold Industries, Inc. 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.

K971483SECURE-WRAP (TM) STERILIZATION WRAP K953878BOUFFANT CAP K953879SURGEON'S CAP K952115BARRIER GOWN, KOOL-GARD BACKLESS GOWN K952114KOOL GARD SINGLES GOWN K952116COVER GOWN

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Related Devices (Code: FRG)

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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.