FDA 510(k) Application Details - K990355

Device Classification Name Wire, Surgical

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510(K) Number K990355
Device Name Wire, Surgical
Applicant BREGMA INTERNATIONAL TRADING COMPANY LTD.
214-111 RESEARCH DR.
SASKATOON, SASKATCHEWAN S7N 3R2 CA
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Contact ASSEM HEDAYAT
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Regulation Number 000.0000

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Classification Product Code LRN
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Date Received 02/05/1999
Decision Date 07/08/1999
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



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