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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 NO. PASTORIA AVE.
SUNNYVALE,  CA  94086
Applicant Contact THOMAS C WEHMAN
Correspondent
NOVASYS MEDICAL, INC.
687 NO. 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
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