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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K955140
Device Name 2.0 X 6MM SCREW
Applicant
Brasseler USA I, L.P.
800 King George Blvd.
Savannah,  GA  31405
Applicant Contact COURTNEY S PARADICE
Correspondent
Brasseler USA I, L.P.
800 King George Blvd.
Savannah,  GA  31405
Correspondent Contact COURTNEY S PARADICE
Regulation Number872.4880
Classification Product Code
DZL  
Date Received11/13/1995
Decision Date 01/05/1996
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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