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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, Electric
510(k) Number K944730
Device Name MASSAGER
Applicant
NORTH AMERICAN TECHNICAL SERVICES CORP.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
NORTH AMERICAN TECHNICAL SERVICES CORP.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number890.5660
Classification Product Code
ISA  
Date Received09/26/1994
Decision Date 02/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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