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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 K941453
Device Name CHECK VALVE SOLUTION SET
Applicant
Douglas Medical Products Corp.
345 Dunbar Rd.
Mundelein,  IL  60060
Applicant Contact DOUGLAS JOHNSON
Correspondent
Douglas Medical Products Corp.
345 Dunbar Rd.
Mundelein,  IL  60060
Correspondent Contact DOUGLAS JOHNSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/25/1994
Decision Date 08/16/1994
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
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