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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K895422
Device Name TOWER SELF SEAL STERILIZATION POUCH
Applicant
Baxter Healthcare Corp
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Applicant Contact JAN L ZORN
Correspondent
Baxter Healthcare Corp
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Correspondent Contact JAN L ZORN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/01/1989
Decision Date 11/29/1989
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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