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FDA 510(k)

MAZING HEAT DISPOSABLE WARM PACK

K-Number: K860444 · 1986-02-27

ApplicantLeebryan Intl.
Decision Date1986-02-27
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MAZING HEAT DISPOSABLE WARM PACK is the device name listed in this FDA 510(k) record. The listed applicant is Leebryan Intl.. It received FDA 510(k) clearance on 1986-02-27 under 510(k) number K860444. 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 MAZING HEAT DISPOSABLE WARM PACK?

MAZING HEAT DISPOSABLE WARM PACK is a medical device that received FDA 510(k) clearance on 1986-02-27. The listed applicant is Leebryan Intl.. The 510(k) number is K860444.

When did MAZING HEAT DISPOSABLE WARM PACK receive FDA 510(k) clearance?

MAZING HEAT DISPOSABLE WARM PACK received FDA 510(k) clearance on 1986-02-27, under 510(k) number K860444.

Who is the listed applicant for MAZING HEAT DISPOSABLE WARM PACK?

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

What is the FDA product code for MAZING HEAT DISPOSABLE WARM PACK?

The FDA product code for MAZING HEAT DISPOSABLE WARM PACK is IMD.

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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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