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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K233222
Device Name Aygün Sterilization Container Systems
Applicant
Aygun Surgical Instruments Co., Inc.
Organize Sanayi Bolgesi
Kutlukent,  TR 55330
Applicant Contact Engin Basoglu
Correspondent
Licensale, Inc.
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/28/2023
Decision Date 12/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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