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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Obturator, For Endoscope
510(k) Number K001328
Device Name INTRODUCER SHEATH
Applicant
Novasys Medical, Inc.
687 # Pastoria Ave.
Sunnyvale,  CA  94086
Applicant Contact THOMAS C WEHMAN
Correspondent
Novasys Medical, Inc.
687 # Pastoria Ave.
Sunnyvale,  CA  94086
Correspondent Contact THOMAS C WEHMAN
Regulation Number876.1500
Classification Product Code
FEC  
Subsequent Product Code
FED  
Date Received04/26/2000
Decision Date 07/17/2000
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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