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FDA 510(k)

SHOE COVER

K-Number: K972227 · 1997-09-09

ApplicantAmerican Seal Co.
Decision Date1997-09-09
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHOE COVER is the device name listed in this FDA 510(k) record. The listed applicant is American Seal Co.. It received FDA 510(k) clearance on 1997-09-09 under 510(k) number K972227. 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 SHOE COVER?

SHOE COVER is a medical device that received FDA 510(k) clearance on 1997-09-09. The listed applicant is American Seal Co.. The 510(k) number is K972227.

When did SHOE COVER receive FDA 510(k) clearance?

SHOE COVER received FDA 510(k) clearance on 1997-09-09, under 510(k) number K972227.

Who is the listed applicant for SHOE COVER?

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

What is the FDA product code for SHOE COVER?

The FDA product code for SHOE COVER is FYF.

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Other records listing American Seal 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.

K972187BOUFFANT CAPK970814NON-STERILE ISOLATION GOWNK964358AMSEAL SURGICAL FACE MASKK892557MAYTEX NON-STERILE LATEX EXAM GLOVEK892553MAYTEX PATIENT EXAMINATION GLOVES

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.

K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K954454NIOMED SURGICAL HOODAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, Inc.K953879SURGEON'S 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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