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FDA 510(k) Application Details - K082387

Device Classification Name

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510(K) Number K082387
Device Name APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
Applicant AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA, MN US
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Contact SARAH PETERSON
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Regulation Number

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Classification Product Code OTP
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Date Received 08/19/2008
Decision Date 12/04/2008
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review N



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