FDA 510(k) Application Details - K973729

Device Classification Name Implant, Muscle, Pectoralis

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510(K) Number K973729
Device Name Implant, Muscle, Pectoralis
Applicant HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON, WA 98346 US
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Contact ERIK HANSON
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Regulation Number 000.0000

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Classification Product Code MIC
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Date Received 09/30/1997
Decision Date 12/24/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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