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FDA 510(k)

DISPOSABLE SURGERY CAPS & HOODS

K-Number: K810199 · 1981-02-13

ApplicantAnago, Inc.
Decision Date1981-02-13
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SURGERY CAPS & HOODS is the device name listed in this FDA 510(k) record. The listed applicant is Anago, Inc.. It received FDA 510(k) clearance on 1981-02-13 under 510(k) number K810199. 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 DISPOSABLE SURGERY CAPS & HOODS?

DISPOSABLE SURGERY CAPS & HOODS is a medical device that received FDA 510(k) clearance on 1981-02-13. The listed applicant is Anago, Inc.. The 510(k) number is K810199.

When did DISPOSABLE SURGERY CAPS & HOODS receive FDA 510(k) clearance?

DISPOSABLE SURGERY CAPS & HOODS received FDA 510(k) clearance on 1981-02-13, under 510(k) number K810199.

Who is the listed applicant for DISPOSABLE SURGERY CAPS & HOODS?

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

What is the FDA product code for DISPOSABLE SURGERY CAPS & HOODS?

The FDA product code for DISPOSABLE SURGERY CAPS & HOODS is FYF.

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Other records listing Anago, 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.

K925659U.C.E.Z. LENS CLEANER KITK930161ANAGO SPINAL ANESTHESIA TRAYK926590ANAGO DISPOSABLE INSTANT COLD PACKK926137ANAGO FEM-COOL/FEM-COOL PETITEK926589ANAGO WARM PACKK920615ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT

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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.K954454NIOMED SURGICAL HOODAmerasia Corp.K954455NIOMED BOUFFANT CAPSAmerasia 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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