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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K861008
Device Name PERCUTANEOUS CATHETERS
Applicant
Micor, Inc.
9229 Pannier Rd.
Pittsburgh,  PA  15237
Applicant Contact STEPHEN BRUSHEY
Correspondent
Micor, Inc.
9229 Pannier Rd.
Pittsburgh,  PA  15237
Correspondent Contact STEPHEN BRUSHEY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/18/1986
Decision Date 04/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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