FDA 510(k) Application Details - K991877

Device Classification Name Nail, Fixation, Bone

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510(K) Number K991877
Device Name Nail, Fixation, Bone
Applicant INNERVISION, INC.
6258 SHADY GROVE RD. E.
MEMPHIS, TN 38120 US
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Contact FRANK M LEWIS
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Regulation Number 888.3030

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Classification Product Code JDS
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Date Received 06/02/1999
Decision Date 08/06/1999
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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