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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 K122526
Device Name 360 GAS ASSISTED ENDOSCOPIC APPLICATOR
Original Applicant
MICROMEDICS, INC.
1270 eagan industrial rd ste 120
saint paul,  MN  55121
Original Contact jodi l raus
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/20/2012
Decision Date 11/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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