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PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES

FDA 510(k) clearance K072951 · decided 2007-12-19

Clearance details

K-number
K072951
Device name
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
Applicant
Sofradim Production
Decision
Substantially Equivalent
Date received
2007-10-18
Decision date
2007-12-19
Days to decision
62 days
Clearance type
Special
Product code
OTP
Device class
3
Regulation number
884.5980
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Norwalk, CT, US
Third-party review
No
Expedited review
No

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AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K111118)American Medical Systems2011-07-01
RESTORELLE POLYPROPYLENE MESH (K092207)Mpathy Medical Devices, Inc.2009-08-04
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EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP (K090713)American Medical Systems, Inc.2009-04-02
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Recalls involving this device

No recalls on record reference this clearance.