The following data is part of a premarket notification filed by Lifeglobal Group, Llc with the FDA for Lifeglobal Global Total W/hsa, Lifeglobal Global Total For Fertilization W/hsa, Lifeglobal Global Total W/hepes W/hsa.
| Device ID | K142991 |
| 510k Number | K142991 |
| Device Name: | LifeGlobal Global Total W/HSA, LifeGlobal Global Total For Fertilization W/HSA, LifeGlobal Global Total W/HEPES W/HSA |
| 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 | 2014-10-16 |
| Decision Date | 2015-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965020594 | K142991 | 000 |
| 00815965020471 | K142991 | 000 |
| 00815965020464 | K142991 | 000 |
| 00815965020457 | K142991 | 000 |
| 00815965020440 | K142991 | 000 |
| 00815965020433 | K142991 | 000 |
| 00815965020426 | K142991 | 000 |
| 00815965022284 | K142991 | 000 |
| 00815965022277 | K142991 | 000 |
| 00815965020488 | K142991 | 000 |
| 00815965020495 | K142991 | 000 |
| 00815965020501 | K142991 | 000 |
| 00815965020587 | K142991 | 000 |
| 00815965020570 | K142991 | 000 |
| 00815965020563 | K142991 | 000 |
| 00815965020556 | K142991 | 000 |
| 00815965020549 | K142991 | 000 |
| 00815965020532 | K142991 | 000 |
| 00815965020525 | K142991 | 000 |
| 00815965020518 | K142991 | 000 |
| 00815965022260 | K142991 | 000 |