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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Catheter, Fiberoptic, Glass, Ureteral
510(k) Number K941506
Device Name URETERAL ILLUMINATOR
Applicant
Apple Medical Corp.
93 Nashaway Rd.
Bolton,  MA  01740
Applicant Contact R. W SCHAEFER
Correspondent
Apple Medical Corp.
93 Nashaway Rd.
Bolton,  MA  01740
Correspondent Contact R. W SCHAEFER
Regulation Number876.4020
Classification Product Code
FCS  
Date Received03/29/1994
Decision Date 10/05/1994
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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