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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K810849
Device Name CORDIS BIOPSY FORCEPS
Applicant
Cordis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cordis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received03/30/1981
Decision Date 04/17/1981
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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