FDA 510(k) Application Details - K022223

Device Classification Name Elastomer, Silicone Block

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510(K) Number K022223
Device Name Elastomer, Silicone Block
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 874.3620

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Classification Product Code MIB
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Date Received 07/09/2002
Decision Date 08/08/2002
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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