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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 K050650
Device Name NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000
Applicant
Cytyc Surgical Products
1047 Elwell Ct.
Palo Alto,  CA  94303
Applicant Contact JIM TALBOT
Correspondent
Cytyc Surgical Products
1047 Elwell Ct.
Palo Alto,  CA  94303
Correspondent Contact JIM TALBOT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/14/2005
Decision Date 05/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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