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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 K880871
Device Name GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER
Applicant
John Wagner Associates, Inc.
205 Mason Cir.
P.O. Box 4060
Concord,  CA  94520
Applicant Contact ERICH BUSSIAN
Correspondent
John Wagner Associates, Inc.
205 Mason Cir.
P.O. Box 4060
Concord,  CA  94520
Correspondent Contact ERICH BUSSIAN
Regulation Number890.5710
Classification Product Code
IMD  
Date Received03/01/1988
Decision Date 05/20/1988
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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