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FDA 510(k) Application Details - K042914
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K042914
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO, CA 92675 US
Other 510(k) Applications for this Company
Contact
LAURA N KASPEROWICZ
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2004
Decision Date
11/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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