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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image, Illumination, Fiberoptic, For Endoscope
510(k) Number K834576
Device Name REAL FIBER OPTIC URETERAL TRANSILLUMIN
Applicant
Douglas Manufacturer Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Douglas Manufacturer Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
FFS  
Date Received12/29/1983
Decision Date 04/20/1984
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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