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FDA 510(k)

COLD CYCLE, CHEMICAL COLD PACK

K-Number: K780014 · 1978-02-21

ApplicantSignal West
Decision Date1978-02-21
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLD CYCLE, CHEMICAL COLD PACK is the device name listed in this FDA 510(k) record. The listed applicant is Signal West. It received FDA 510(k) clearance on 1978-02-21 under 510(k) number K780014. 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 COLD CYCLE, CHEMICAL COLD PACK?

COLD CYCLE, CHEMICAL COLD PACK is a medical device that received FDA 510(k) clearance on 1978-02-21. The listed applicant is Signal West. The 510(k) number is K780014.

When did COLD CYCLE, CHEMICAL COLD PACK receive FDA 510(k) clearance?

COLD CYCLE, CHEMICAL COLD PACK received FDA 510(k) clearance on 1978-02-21, under 510(k) number K780014.

Who is the listed applicant for COLD CYCLE, CHEMICAL COLD PACK?

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

What is the FDA product code for COLD CYCLE, CHEMICAL COLD PACK?

The FDA product code for COLD CYCLE, CHEMICAL COLD 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 Signal West 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.

K802252HOT CYCLE, A CHEMICAL TYPE HOT PACKK770505SHAKE-N-WARM

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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