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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K901719
Device Name KLEIN MICRO-CANNULA HANDLE(TM)
Applicant
Jeff Klein Surgical, Inc.
P.O. Box 1269
San Clemente,  CA  92674
Applicant Contact JACQUELINE KLEIN
Correspondent
Jeff Klein Surgical, Inc.
P.O. Box 1269
San Clemente,  CA  92674
Correspondent Contact JACQUELINE KLEIN
Regulation Number878.4800
Classification Product Code
GEA  
Date Received04/13/1990
Decision Date 05/22/1990
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
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