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 |