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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 K963220
Device Name TEMPRA COLD PACK, REORDER NO. TC150
Applicant
Tempo Technology, Inc.
5945 N. Washington Blvd.
Sarasota,  FL  34243
Applicant Contact JAY RUEHLEN
Correspondent
Tempo Technology, Inc.
5945 N. Washington Blvd.
Sarasota,  FL  34243
Correspondent Contact JAY RUEHLEN
Regulation Number890.5710
Classification Product Code
IMD  
Date Received08/16/1996
Decision Date 10/10/1996
Decision Substantially Equivalent (SESE)
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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