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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K822806
Device Name BALLOON WEDGE PRESSURE, ANGIOGRAPHIC
Applicant
Nova Medical Specialties
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Nova Medical Specialties
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1240
Classification Product Code
DYG  
Date Received09/17/1982
Decision Date 11/01/1982
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
Recalls CDRH Recalls
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