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FDA 510(k)

NICE PACK

K-Number: K832193 · 1983-08-31

ApplicantUniversal Medical Instrument Corp.
Decision Date1983-08-31
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NICE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832193. 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 NICE PACK?

NICE PACK is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K832193.

When did NICE PACK receive FDA 510(k) clearance?

NICE PACK received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832193.

Who is the listed applicant for NICE PACK?

The FDA 510(k) record lists Universal Medical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICE PACK?

The FDA product code for NICE PACK is IME.

Other records listing Universal Medical Instrument 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.

K962180CATH SEALK935077CATH-SEALK897128UMI BRAIDED CATHETER CONNECTORK881796UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLEK863178UMI STEERABLE TORQUE GUIDE WIREK861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO

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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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