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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K952074
Device Name SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
Applicant
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact MARY ELLEN SNYDER
Correspondent
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact MARY ELLEN SNYDER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/02/1995
Decision Date 07/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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