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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Vacuum
510(k) Number K942747
Device Name MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )
Applicant
Engineered Orthopedic Technologies, Inc.
920-C Calle Negocio
San Clemente,  CA  92672
Applicant Contact JAMES BARLEY
Correspondent
Engineered Orthopedic Technologies, Inc.
920-C Calle Negocio
San Clemente,  CA  92672
Correspondent Contact JAMES BARLEY
Regulation Number880.6740
Classification Product Code
KDP  
Date Received06/10/1994
Decision Date 07/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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