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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 K974642
Device Name COMBICATH CATHETER
Applicant
Plastimed Laboratoire Pharmaceutique
212 3rd Ave. N.
Suite #446
Minneapolis,  MN  55401
Applicant Contact MIKE MCCORMICK
Correspondent
Plastimed Laboratoire Pharmaceutique
212 3rd Ave. N.
Suite #446
Minneapolis,  MN  55401
Correspondent Contact MIKE MCCORMICK
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/15/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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