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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
Predetermined Change
Control Plan Authorized		 No
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