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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Disposable
510(k) Number K951383
Device Name TEMPRA HEAT PACK
Applicant
Tempra Technology, Inc.
5945 N. Washington Blvd.
Sarasota,  FL  34243
Applicant Contact JAY RUEHLEN
Correspondent
Tempra Technology, Inc.
5945 N. Washington Blvd.
Sarasota,  FL  34243
Correspondent Contact JAY RUEHLEN
Regulation Number890.5710
Classification Product Code
IMD  
Date Received03/27/1995
Decision Date 06/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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