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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 K951522
Device Name WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA
Applicant
Woodbine Optical Corp.
41 Brooks Dr.
Braintree,  MA  02184
Applicant Contact ROBERT H SEGERSTEN
Correspondent
Woodbine Optical Corp.
41 Brooks Dr.
Braintree,  MA  02184
Correspondent Contact ROBERT H SEGERSTEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/03/1995
Decision Date 06/16/1995
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
Predetermined Change
Control Plan Authorized		 No
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