Atlas FDA

SURELIFT PROLAPSE SYSTEM

FDA 510(k) clearance K102815 · decided 2011-07-07

Clearance details

K-number
K102815
Device name
SURELIFT PROLAPSE SYSTEM
Applicant
Neomedic International
Decision
Substantially Equivalent
Date received
2010-09-28
Decision date
2011-07-07
Days to decision
282 days
Clearance type
Traditional
Product code
OTP
Device class
3
Regulation number
884.5980
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.