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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K131401
Device Name BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
Applicant
MERCATOR MEDSYSTEMS, INC.
1670 ALVARADO SUITE #4
SAN LEANDRO,  CA  94577
Applicant Contact PLAMENA ENTCHEVA-DIMITROV, PHD
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received05/15/2013
Decision Date 07/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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