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FDA 510(k)

INSTANT WARM GEL PACK

K-Number: K912715 · 1991-10-02

ApplicantPrism Technologies, Inc.
Decision Date1991-10-02
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INSTANT WARM GEL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Prism Technologies, Inc.. It received FDA 510(k) clearance on 1991-10-02 under 510(k) number K912715. 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 INSTANT WARM GEL PACK?

INSTANT WARM GEL PACK is a medical device that received FDA 510(k) clearance on 1991-10-02. The listed applicant is Prism Technologies, Inc.. The 510(k) number is K912715.

When did INSTANT WARM GEL PACK receive FDA 510(k) clearance?

INSTANT WARM GEL PACK received FDA 510(k) clearance on 1991-10-02, under 510(k) number K912715.

Who is the listed applicant for INSTANT WARM GEL PACK?

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

What is the FDA product code for INSTANT WARM GEL PACK?

The FDA product code for INSTANT WARM GEL PACK is IMD.

Related Clinical Trials

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.

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Other records listing Prism Technologies, 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.

K980212MITYVACK953542COLDGELK953541INSTANT COLDGELK934631TRANSWARMER

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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