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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Film, X-Ray
510(k) Number K913168
Device Name SALIBAG
Applicant
Nix Co. , Ltd.
C/O Meadox Consulting Services
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact PATRICIA CHRISTIAN
Correspondent
Nix Co. , Ltd.
C/O Meadox Consulting Services
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact PATRICIA CHRISTIAN
Regulation Number872.1905
Classification Product Code
EGZ  
Date Received07/17/1991
Decision Date 09/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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