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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Special Lens, For Endoscope
510(k) Number K873795
Device Name M-LENS (THIRTY DEGREE ENDOSCOPE)
Applicant
Opto Vision, Inc.
4849 N. Kenneth Ave.
Chicago,  IL  60630
Applicant Contact HELMUT KREBS
Correspondent
Opto Vision, Inc.
4849 N. Kenneth Ave.
Chicago,  IL  60630
Correspondent Contact HELMUT KREBS
Regulation Number876.1500
Classification Product Code
FEI  
Date Received09/17/1987
Decision Date 01/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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