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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lock, Wire, And Ligature, Intraoral
510(k) Number K030605
FOIA Releasable 510(k) K030605
Device Name RAPID IMF
Applicant
ZYGOMATICS LTD.
20A MONTPELIER VALE
LONDON SE3 0TA,  GB
Applicant Contact CAROL MACDONALD
Correspondent
ZYGOMATICS LTD.
20A MONTPELIER VALE
LONDON SE3 0TA,  GB
Correspondent Contact CAROL MACDONALD
Regulation Number872.4600
Classification Product Code
DYX  
Date Received02/25/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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