FDA 510(k) Application Details - K021337

Device Classification Name Implant, Muscle, Pectoralis

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510(K) Number K021337
Device Name Implant, Muscle, Pectoralis
Applicant AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
5871 LONE PINE PLACE
PASO ROBLES, CA 93446 US
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Contact CATHERINE RIPLE
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Regulation Number 000.0000

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Classification Product Code MIC
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Date Received 04/26/2002
Decision Date 07/03/2002
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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