The following data is part of a premarket notification filed by Lifeglobal Group, Llc with the FDA for Lifeglobal Global Hp.
| Device ID | K143498 |
| 510k Number | K143498 |
| Device Name: | LifeGlobal Global HP |
| Classification | Media, Reproductive |
| Applicant | LifeGlobal Group, LLC 393 Soundview Road Guilford, CT 06437 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi LifeGlobal Group, LLC 393 Soundview Road Guilford, CT 06437 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-10 |
| Decision Date | 2015-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965020419 | K143498 | 000 |
| 00815965020402 | K143498 | 000 |