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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K130581
Device Name KONIX STERILE GEL
Applicant
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
2237 Chestnut St.
San Francisco,  CA  94123
Applicant Contact MICHAEL SCOTT, REGULATORY AGENT
Correspondent
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
2237 Chestnut St.
San Francisco,  CA  94123
Correspondent Contact MICHAEL SCOTT, REGULATORY AGENT
Regulation Number892.1570
Classification Product Code
MUI  
Date Received03/05/2013
Decision Date 06/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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