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FDA 510(k)

P.S.M. BOTIQUE CAP

K-Number: K761069 · 1976-12-30

ApplicantThe Owenby Co.
Decision Date1976-12-30
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

P.S.M. BOTIQUE CAP is the device name listed in this FDA 510(k) record. The listed applicant is The Owenby Co.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K761069. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.S.M. BOTIQUE CAP?

P.S.M. BOTIQUE CAP is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is The Owenby Co.. The 510(k) number is K761069.

When did P.S.M. BOTIQUE CAP receive FDA 510(k) clearance?

P.S.M. BOTIQUE CAP received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761069.

Who is the listed applicant for P.S.M. BOTIQUE CAP?

The FDA 510(k) record lists The Owenby Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P.S.M. BOTIQUE CAP?

The FDA product code for P.S.M. BOTIQUE CAP is FYF.

Related Clinical Trials

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Other records listing The Owenby Co. 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.

K801628RESTRAINT, PROTECTIVEK801627COVER, LIMBK801626ARM SLINGK801532STOCKINETTE, STERILE TWO PLY W/PULL TABSK801531ARM SLINGK790210STOCKINETTE, TUBULAR UNBLEACHED

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Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K954454NIOMED SURGICAL HOODAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, Inc.

Official Source

View on FDA Database →

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

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