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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
Applicant
Lewtek
13360 Rim Rock Dr.
Reno,  NV  89511
Applicant Contact RAYMON A LEWIS
Correspondent
Lewtek
13360 Rim Rock Dr.
Reno,  NV  89511
Correspondent Contact RAYMON A LEWIS
Regulation Number876.1500
Classification Product Code
GCJ  
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
Predetermined Change
Control Plan Authorized		 No
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