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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 K946171
Device Name VIDEO ENDOSCOPE SYSTEM WITH ZOOM
Applicant
Oktas
134 Flanders Rd.
Westborough,  MA  01581
Applicant Contact RICHARD SCHERMERHORN
Correspondent
Oktas
134 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact RICHARD SCHERMERHORN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/19/1994
Decision Date 01/26/1995
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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