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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, fiber optic
510(k) Number K855151
Device Name FRITCH OPHTHALMIC ENDOSCOPE
Applicant
REGTEC
P.O. BOX 76298
ST. PETERSBURG,  FL  33734
Applicant Contact JOANN R SCHULZ
Correspondent
REGTEC
P.O. BOX 76298
ST. PETERSBURG,  FL  33734
Correspondent Contact JOANN R SCHULZ
Regulation Number876.1500
Classification Product Code
GDB  
Date Received12/26/1985
Decision Date 02/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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