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FDA 510(k)

THERMOELASTOMER HOT/COLD COMPRESS BK7186

K-Number: K823649 · 1983-01-21

ApplicantFred Sammons, Inc.
Decision Date1983-01-21
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMOELASTOMER HOT/COLD COMPRESS BK7186 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 1983-01-21 under 510(k) number K823649. 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 THERMOELASTOMER HOT/COLD COMPRESS BK7186?

THERMOELASTOMER HOT/COLD COMPRESS BK7186 is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K823649.

When did THERMOELASTOMER HOT/COLD COMPRESS BK7186 receive FDA 510(k) clearance?

THERMOELASTOMER HOT/COLD COMPRESS BK7186 received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823649.

Who is the listed applicant for THERMOELASTOMER HOT/COLD COMPRESS BK7186?

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 THERMOELASTOMER HOT/COLD COMPRESS BK7186?

The FDA product code for THERMOELASTOMER HOT/COLD COMPRESS BK7186 is IME.

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Other records listing Fred Sammons, 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.

K880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)K880647ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)K831549ARM SLINGSK831548SPLINTSK831550FINGER BONIOMETER BK7506K831544DELUXE TRACTION EXERCISE GLOVE BK5035

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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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