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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 K930986
Device Name BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560
Applicant
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Applicant Contact FELIX B SANTOS
Correspondent
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Correspondent Contact FELIX B SANTOS
Regulation Number868.1100
Classification Product Code
CBT  
Date Received02/25/1993
Decision Date 07/14/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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