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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Heart-Valve, Prosthesis
510(k) Number K811235
Device Name DISPOSABLE HOLDER FOR HANCOCK MITRAL
Applicant
Vascor, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vascor, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3935
Classification Product Code
DTJ  
Date Received05/04/1981
Decision Date 05/13/1981
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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