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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K921883
Device Name ENDOSCOPE
Applicant
Optimed Technologies, Inc.
2440 N. Glassell St.
Suite J
Orange,  CA  92665
Applicant Contact RONALD J EHMSEN
Correspondent
Optimed Technologies, Inc.
2440 N. Glassell St.
Suite J
Orange,  CA  92665
Correspondent Contact RONALD J EHMSEN
Regulation Number876.1500
Classification Product Code
GCM  
Date Received04/21/1992
Decision Date 11/23/1992
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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