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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Defibrillator
510(k) Number K961595
Device Name DEFIBRILLATOR ANALYZER, DELTA 1000
Applicant
Netech Corp.
30 Northport Rd.
Sound Beach,  NY  11789 -1734
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
Netech Corp.
30 Northport Rd.
Sound Beach,  NY  11789 -1734
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number870.5325
Classification Product Code
DRL  
Date Received04/24/1996
Decision Date 10/29/1996
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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