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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K874688
Device Name FLOWTRON AC200/2
Applicant
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Applicant Contact JAMES BRITTON
Correspondent
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Correspondent Contact JAMES BRITTON
Regulation Number890.5650
Classification Product Code
IRP  
Date Received11/13/1987
Decision Date 09/23/1988
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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