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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Manual
510(k) Number K930613
Device Name HOOKING SYSTEM
Applicant
Alain Machtelinckx
2148 Club House Dr.
West Linn,  OR  97068
Applicant Contact ALAIN MACHTELINCKX
Correspondent
Alain Machtelinckx
2148 Club House Dr.
West Linn,  OR  97068
Correspondent Contact ALAIN MACHTELINCKX
Regulation Number890.5660
Classification Product Code
LYG  
Date Received02/05/1993
Decision Date 07/12/1994
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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