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FDA 510(k)

THERMO-PACK

K-Number: K890924 · 1989-03-14

ApplicantMedical Manufacturers, Inc.
Decision Date1989-03-14
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMO-PACK is the device name listed in this FDA 510(k) record. The listed applicant is Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K890924. 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 THERMO-PACK?

THERMO-PACK is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Medical Manufacturers, Inc.. The 510(k) number is K890924.

When did THERMO-PACK receive FDA 510(k) clearance?

THERMO-PACK received FDA 510(k) clearance on 1989-03-14, under 510(k) number K890924.

Who is the listed applicant for THERMO-PACK?

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

What is the FDA product code for THERMO-PACK?

The FDA product code for THERMO-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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Manufacturers, 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.

K925424MEDICAL MANUFACTURING INC GAS SAMPLING LINES&CONN.

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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