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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K962651
Device Name S-52 ELECTRONIC VIDEO LAPAROSCOPE
Applicant
DEL MEDICAL SYSTEMS CORP.
19 JEFRYN BOULEVARD WEST
DEER PARK,  NY  11729
Applicant Contact KARL J WEYDIG
Correspondent
DEL MEDICAL SYSTEMS CORP.
19 JEFRYN BOULEVARD WEST
DEER PARK,  NY  11729
Correspondent Contact KARL J WEYDIG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/08/1996
Decision Date 09/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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