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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K945862
Device Name ENDCUP
13360 RIM ROCK DR.
RENO,  NV  89511
Applicant Contact RAYMON A LEWIS
13360 RIM ROCK DR.
RENO,  NV  89511
Correspondent Contact RAYMON A LEWIS
Regulation Number876.1500
Classification Product Code
Date Received12/01/1994
Decision Date 02/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No