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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function
510(k) Number K961582
Device Name EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
Applicant
North American Technical Services Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
North American Technical Services Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number870.3630
Classification Product Code
DTC  
Date Received04/24/1996
Decision Date 11/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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