The following data is part of a premarket notification filed by Medipurpose Pte. Ltd. with the FDA for Babylance Heel Incision Device , Models Blp50, Blp200, Bln50, Bln200.
| Device ID | K101417 |
| 510k Number | K101417 |
| Device Name: | BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-20 |
| Decision Date | 2010-10-19 |
| Summary: | summary |