FDA 510(k) Premarket Notification K130132: BABYLANCE HEEL INCISION DEVICE

Submission Details & Decision

Normalized public record details for 510(k) notification K130132.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K130132

Applicant / Sponsor

Medipurpose Pte. , Ltd.

Device Name

BABYLANCE HEEL INCISION DEVICE

Product Code

FMK

Decision Date

2013-02-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Special

Third Party Flag

Date Received

2013-01-18

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