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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 K012150
Device Name PATTON ENDO-BAG
Applicant
PATTON MEDICAL CORP.
1000 WESTBANK DR.
SUITE 5A200
AUSTIN,  TX  78746
Applicant Contact MICHAEL T PATTON
Correspondent
PATTON MEDICAL CORP.
1000 WESTBANK DR.
SUITE 5A200
AUSTIN,  TX  78746
Correspondent Contact MICHAEL T PATTON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/10/2001
Decision Date 09/20/2001
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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