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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K083722
Device Name ASCEND
Applicant
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301
Applicant Contact MARA KORSUNSKY
Correspondent
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301
Correspondent Contact MARA KORSUNSKY
Regulation Number884.5980
Classification Product Code
OTP  
Date Received12/15/2008
Decision Date 03/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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