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FDA 510(k)

KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)

K-Number: K970399 · 1997-04-03

ApplicantAllegiance Healthcare Corp.
Decision Date1997-04-03
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 1997-04-03 under 510(k) number K970399. 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 KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)?

KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K970399.

When did KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) receive FDA 510(k) clearance?

KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) received FDA 510(k) clearance on 1997-04-03, under 510(k) number K970399.

Who is the listed applicant for KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)?

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

What is the FDA product code for KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)?

The FDA product code for KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) is IMD.

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Other records listing Allegiance Healthcare Corp. 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.

K023673AIRLIFE DEMAND NASAL CANNULAK023419TRILAMINATE DRAPES/TIBURONK024120MODIFICATION TO TEMNO BIOPSY NEEDLESK024292MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIMK024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK023425DRAPES WITH ABSORBENT REINFORCEMENT

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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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