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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, abortion, vacuum
510(k) Number K931205
Device Name MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER
Applicant
BAXTER HEALTHCARE CORP.
1425 LAKE COOK RD.
DEERFIELD,  IL  60015
Applicant Contact INGRID M HOOS
Correspondent
BAXTER HEALTHCARE CORP.
1425 LAKE COOK RD.
DEERFIELD,  IL  60015
Correspondent Contact INGRID M HOOS
Regulation Number884.5070
Classification Product Code
HHI  
Subsequent Product Code
GCX  
Date Received03/09/1993
Decision Date 03/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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