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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suspension, Cell Culture
510(k) Number K893787
Device Name LIFECELL RECOVERY CONTAINER
Applicant
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact DONALD H BUCHHOLZ
Correspondent
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact DONALD H BUCHHOLZ
Regulation Number864.2240
Classification Product Code
KJF  
Date Received05/22/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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