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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 K970056
Device Name SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
Applicant
WOODBINE OPTICAL CORP.
41 BROOKS DR.
BRAINTREE,  MA  02184
Applicant Contact PAUL DIAS
Correspondent
WOODBINE OPTICAL CORP.
41 BROOKS DR.
BRAINTREE,  MA  02184
Correspondent Contact PAUL DIAS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/07/1997
Decision Date 01/28/1997
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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