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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 K960301
Device Name ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR
Applicant
DEL MEDICAL SYSTEMS CORP.
ONE COMMERCE PARK
VALHALLA,  NY  10595
Applicant Contact KARL WEYDIG
Correspondent
DEL MEDICAL SYSTEMS CORP.
ONE COMMERCE PARK
VALHALLA,  NY  10595
Correspondent Contact KARL WEYDIG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/22/1996
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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