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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arterial Blood Sampling Kit
510(k) Number K872244
Device Name CORD-ASSURE UMBILICAL BLOOD GAS KIT
Applicant
LAKE MEDICAL PRODUCTS, INC.
11866 ADIE RD.
MARYLAND HEIGHTS,  MO  63043
Applicant Contact ELI SCHACHET
Correspondent
LAKE MEDICAL PRODUCTS, INC.
11866 ADIE RD.
MARYLAND HEIGHTS,  MO  63043
Correspondent Contact ELI SCHACHET
Regulation Number868.1100
Classification Product Code
CBT  
Date Received06/11/1987
Decision Date 07/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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