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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 K931873
Device Name VACVENT
Applicant
STEVEN FRANK MERCEREAU
4911 WEST LAKE DR.
CONYERS,  GA  30208
Applicant Contact STEVEN F MERCEREAU
Correspondent
STEVEN FRANK MERCEREAU
4911 WEST LAKE DR.
CONYERS,  GA  30208
Correspondent Contact STEVEN F MERCEREAU
Regulation Number868.1100
Classification Product Code
CBT  
Date Received04/14/1993
Decision Date 12/30/1993
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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