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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K831931
Device Name ATRIUM THORACIC CATHETER
Applicant
ATRIUM MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ATRIUM MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received06/15/1983
Decision Date 10/04/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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