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FDA 510(k) Application Details - K934183
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
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510(K) Number
K934183
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
APOGEE MEDICAL PRODUCTS, INC.
PO BOX 1387
EFFINGHAM, IL 62401 US
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Contact
BRYAN G MILLER
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Regulation Number
888.3040
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Classification Product Code
MBI
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More FDA Info for this Product Code
Date Received
08/26/1993
Decision Date
04/03/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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