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FDA 510(k) Application Details - K021337
Device Classification Name
Implant, Muscle, Pectoralis
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MIC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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