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FDA 510(k)

COLD/HOT PACK

K-Number: K803299 · 1981-01-15

ApplicantW.G. Whitney Corp.
Decision Date1981-01-15
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLD/HOT PACK is the device name listed in this FDA 510(k) record. The listed applicant is W.G. Whitney Corp.. It received FDA 510(k) clearance on 1981-01-15 under 510(k) number K803299. 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 COLD/HOT PACK?

COLD/HOT PACK is a medical device that received FDA 510(k) clearance on 1981-01-15. The listed applicant is W.G. Whitney Corp.. The 510(k) number is K803299.

When did COLD/HOT PACK receive FDA 510(k) clearance?

COLD/HOT PACK received FDA 510(k) clearance on 1981-01-15, under 510(k) number K803299.

Who is the listed applicant for COLD/HOT PACK?

The FDA 510(k) record lists W.G. Whitney Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLD/HOT PACK?

The FDA product code for COLD/HOT PACK is IME.

Other records listing W.G. Whitney Corp. 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.

K834532STERILE WET DRESSING PACKK813535XEROFORM DRESSINGK810406STERILE WET DRESSING PACKK800907TOMAC WET DRESSING WARMERK781322STERILE WET DRESSING PACKK770387UNICATCH

View all 7 devices →

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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