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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 K123847
Device Name MALLEABLE TIP ENDOSCOPIC APPLICATOR
Applicant
MICROMEDICS, INC.
1270 Eagan Industrial Rd Ste 120
Saint Paul,  MN  55121
Applicant Contact JODI L RAUS
Correspondent
MICROMEDICS, INC.
1270 Eagan Industrial Rd Ste 120
Saint Paul,  MN  55121
Correspondent Contact JODI L RAUS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/14/2012
Decision Date 01/08/2013
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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