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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 K901834
Device Name INSTANT ICE PACK
Applicant
Impact Packaging Corp.
770 Sycamore Ave.
Suite J-439
Vista,  CA  92083
Applicant Contact BRIAN R PIKE
Correspondent
Impact Packaging Corp.
770 Sycamore Ave.
Suite J-439
Vista,  CA  92083
Correspondent Contact BRIAN R PIKE
Regulation Number890.5710
Classification Product Code
IMD  
Date Received04/24/1990
Decision Date 05/03/1990
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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