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FDA 510(k)

ANAGO FEM-COOL/FEM-COOL PETITE

K-Number: K926137 · 1993-05-26

ApplicantAnago, Inc.
Decision Date1993-05-26
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ANAGO FEM-COOL/FEM-COOL PETITE is the device name listed in this FDA 510(k) record. The listed applicant is Anago, Inc.. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K926137. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANAGO FEM-COOL/FEM-COOL PETITE?

ANAGO FEM-COOL/FEM-COOL PETITE is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Anago, Inc.. The 510(k) number is K926137.

When did ANAGO FEM-COOL/FEM-COOL PETITE receive FDA 510(k) clearance?

ANAGO FEM-COOL/FEM-COOL PETITE received FDA 510(k) clearance on 1993-05-26, under 510(k) number K926137.

Who is the listed applicant for ANAGO FEM-COOL/FEM-COOL PETITE?

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 ANAGO FEM-COOL/FEM-COOL PETITE?

The FDA product code for ANAGO FEM-COOL/FEM-COOL PETITE is IMD.

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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 PACKK926589ANAGO WARM PACKK920615ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KITK915415GUARDALL SHIELD

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Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, 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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