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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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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