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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Allergen And Vaccine Delivery Needles
510(k) Number K250983
Device Name Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
Applicant
Asistan Medikal
Havaalani Organize Sanayi Bolgesi
Korkun Mahallesi 103. Cadde No:6
Oguzeli, Gaziantep,  TR 2760
Applicant Contact Ibrahim Muhittin Tuzcu
Correspondent
510K FDA, Inc.
156 E. Granada Blvd.
Ormond Beach,  FL  32176
Correspondent Contact Lee Strong
Regulation Number880.5570
Classification Product Code
SCL  
Date Received03/31/2025
Decision Date 01/30/2026
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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