FDA 510(k) Application Details - K021063

Device Classification Name Prosthesis, Toe, Hemi-, Phalangeal

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510(K) Number K021063
Device Name Prosthesis, Toe, Hemi-, Phalangeal
Applicant SIGNAL MEDICAL CORP.
3777 LAPEER RD. 3-C
PORT HURON, MI 48060 US
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Contact LOUIS A SERAFIN
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Regulation Number 888.3730

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Classification Product Code KWD
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Date Received 04/02/2002
Decision Date 07/01/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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