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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 K171533
Device Name Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
Applicant
Ahlstrom Nonwovens, LLC
2 Elm St.
Windsor Locks,  CT  06096
Applicant Contact Gary Jackson
Correspondent
Ajw Technology Consultants, Inc.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact Lauren Chrapowitzky
Regulation Number880.6850
Classification Product Code
FRG  
Date Received05/25/2017
Decision Date 06/29/2017
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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