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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 K893764
Device Name STERILIZATION TRAY LINER
Applicant
Ahlstrom Dexter
Two Elm St.
Windsor Locks,  CT  06096
Applicant Contact H. A HOFFMAN
Correspondent
Ahlstrom Dexter
Two Elm St.
Windsor Locks,  CT  06096
Correspondent Contact H. A HOFFMAN
Regulation Number880.6850
Classification Product Code
FRG  
Date Received05/19/1989
Decision Date 08/15/1989
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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