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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dispenser, Solid Medication
510(k) Number K882731
Device Name TAB PAK
Applicant
DYNEX TRADING CO.
6636 TELEGRAPH AVE.
OAKLAND,  CA  94609
Applicant Contact GREGORY LAN
Correspondent
DYNEX TRADING CO.
6636 TELEGRAPH AVE.
OAKLAND,  CA  94609
Correspondent Contact GREGORY LAN
Regulation Number890.5050
Classification Product Code
NXB  
Date Received07/01/1988
Decision Date 12/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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