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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K874492
Device Name LAWRENCE L4000 REFLECTANCE PULSE OXIMETER
Applicant
Lawrence Medical Systems, Inc.
1100 Avenida Acaso
Cammarillo,  CA  93010
Applicant Contact DONALD R STEELE
Correspondent
Lawrence Medical Systems, Inc.
1100 Avenida Acaso
Cammarillo,  CA  93010
Correspondent Contact DONALD R STEELE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/02/1987
Decision Date 03/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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