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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K790124
Device Name GRAFT TUNNELER
Applicant
Narco Scientific
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Narco Scientific
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.4500
Classification Product Code
DWS  
Date Received01/23/1979
Decision Date 02/08/1979
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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