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FDA 510(k)

BK-7182 INSTANT COLD PACK

K-Number: K813628 · 1982-01-19

ApplicantFred Sammons, Inc.
Decision Date1982-01-19
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BK-7182 INSTANT COLD PACK is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1982-01-19 under 510(k) number K813628. 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 BK-7182 INSTANT COLD PACK?

BK-7182 INSTANT COLD PACK is a medical device that received FDA 510(k) clearance on 1982-01-19. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K813628.

When did BK-7182 INSTANT COLD PACK receive FDA 510(k) clearance?

BK-7182 INSTANT COLD PACK received FDA 510(k) clearance on 1982-01-19, under 510(k) number K813628.

Who is the listed applicant for BK-7182 INSTANT COLD PACK?

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

What is the FDA product code for BK-7182 INSTANT COLD PACK?

The FDA product code for BK-7182 INSTANT COLD PACK is IMD.

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Other records listing Fred Sammons, 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.

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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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