The following data is part of a premarket notification filed by Medipurpose Pte. Ltd. with the FDA for Babylance Heel Incision Device.
Device ID | K130132 |
510k Number | K130132 |
Device Name: | BABYLANCE HEEL INCISION DEVICE |
Classification | Lancet, Blood |
Applicant | MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
Contact | Julie Stephens |
Correspondent | Julie Stephens MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
Product Code | FMK |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-18 |
Decision Date | 2013-02-11 |
Summary: | summary |