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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 K853045
Device Name ALLY PORTABLE NOT PACK/PAD DISPOSABLE
Applicant
Actin International, Inc.
17 Danbury Rd.
Ridgefield,  CT  06877
Applicant Contact ROBERT B TRUMBULL
Correspondent
Actin International, Inc.
17 Danbury Rd.
Ridgefield,  CT  06877
Correspondent Contact ROBERT B TRUMBULL
Regulation Number890.5710
Classification Product Code
IMD  
Date Received07/19/1985
Decision Date 09/06/1985
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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