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FDA 510(k)

REUSEABLE HOT & COLD PACKS

K-Number: K810451 · 1981-03-04

ApplicantFred Sammons, Inc.
Decision Date1981-03-04
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REUSEABLE HOT & COLD PACKS 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 1981-03-04 under 510(k) number K810451. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REUSEABLE HOT & COLD PACKS?

REUSEABLE HOT & COLD PACKS is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K810451.

When did REUSEABLE HOT & COLD PACKS receive FDA 510(k) clearance?

REUSEABLE HOT & COLD PACKS received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810451.

Who is the listed applicant for REUSEABLE HOT & COLD PACKS?

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 REUSEABLE HOT & COLD PACKS?

The FDA product code for REUSEABLE HOT & COLD PACKS is IME.

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Other records listing Fred Sammons, Inc. as applicant

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Related Devices (Code: IME)

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.

K923627COLD PACKFriendmed ProductsK915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK863654RE-HEATER, HOT PACKK & L Ent.

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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