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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K914457
Device Name DISPOSABLE OPTICAL VALVULOTOME
Applicant
Nobles-Lai Engineering, Inc.
3178 Pullman St.
Costa Mesa,  CA  92626
Applicant Contact KAREN U SALINAS
Correspondent
Nobles-Lai Engineering, Inc.
3178 Pullman St.
Costa Mesa,  CA  92626
Correspondent Contact KAREN U SALINAS
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received10/07/1991
Decision Date 02/05/1992
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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