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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 K252823
Device Name Dukal Crepe Paper Sterilization Wrap
Applicant
Dukal, LLC
2 Fleetwood Ct.
Ronkonkoma,  NY  11779
Applicant Contact William Bagnasco
Correspondent
Dukal, LLC
2 Fleetwood Ct.
Ronkonkoma,  NY  11779
Correspondent Contact William Bagnasco
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/04/2025
Decision Date 05/28/2026
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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