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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 K080161
Device Name PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
Applicant
PATTON SURGICAL CORP.
6300 BRIDGEPOINT PKWY.
BLDG. 2, STE. 420
AUSTIN,  TX  78730
Applicant Contact MICHAEL PATTON
Correspondent
PATTON SURGICAL CORP.
6300 BRIDGEPOINT PKWY.
BLDG. 2, STE. 420
AUSTIN,  TX  78730
Correspondent Contact MICHAEL PATTON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/23/2008
Decision Date 05/29/2008
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
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