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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K832753
Device Name PERCUTANEOUS BALLOON
Applicant
Smec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Smec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3535
Classification Product Code
DSP  
Date Received08/15/1983
Decision Date 10/13/1984
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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