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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 K230137
Device Name Reliance® Fusion Sterilization Wraps
Applicant
Ahlstrom-Munksjo Nonwovens, LLC
2 Elm St.
Windsor Locks,  CT  06096
Applicant Contact Gary Jackson
Correspondent
Ajw Technology Consultants, Inc.
11705 Boyette Rd., Suite #503
Riverview,  FL  33569
Correspondent Contact Ryan Burke
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/18/2023
Decision Date 12/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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