FDA 510(k) Application Details - K990351

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K990351
Device Name	Screw, Fixation, Bone
Applicant	BREGMA INTERNATIONAL TRADING COMPANY LTD. 214-111 RESEARCH DR. SASKATOON, SASKATCHEWAN S7N 3R2 CA Other 510(k) Applications for this Company
Contact	ASSEM HEDAYAT Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/1999
Decision Date	06/01/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review