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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 K960624
Device Name CERTI COOL INSTANT COLD COMPRESS
Applicant
Certified Safety Mfg., Inc.
1400 Chestnut
Kansas City,  MO  64127
Applicant Contact HOWARD GERSON
Correspondent
Certified Safety Mfg., Inc.
1400 Chestnut
Kansas City,  MO  64127
Correspondent Contact HOWARD GERSON
Regulation Number890.5710
Classification Product Code
IMD  
Date Received02/13/1996
Decision Date 05/06/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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