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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K921243
Device Name CONVERTORS STERILIZATION WRAP
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact THOMAS J MOUTVIC
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact THOMAS J MOUTVIC
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/13/1992
Decision Date 10/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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