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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 K933776
Device Name OPTIK LAPAROSCOPE
Applicant
OPTIK
1370 BLAIR DR.
ODENTON,  MD  21113
Applicant Contact WILLIAM M MACFIE
Correspondent
OPTIK
1370 BLAIR DR.
ODENTON,  MD  21113
Correspondent Contact WILLIAM M MACFIE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/03/1993
Decision Date 03/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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