The following data is part of a premarket notification filed by Lifelong Meditech Private Limited with the FDA for Safeway, Lifelong Premium, Lifelong Matrix.
| Device ID | K210103 |
| 510k Number | K210103 |
| Device Name: | SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX |
| Classification | Syringe, Piston |
| Applicant | Lifelong Meditech Private Limited Plot No.18, Sector-5, IMT Manesar Gurugram, IN 122050 |
| Contact | Hamendra Nath Srivastava |
| Correspondent | Hamendra Nath Srivastava Lifelong Meditech Private Limited Plot No.18, Sector-5, IMT Manesar Gurugram, IN 122050 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-14 |
| Decision Date | 2021-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18906067662399 | K210103 | 000 |
| 28906067662389 | K210103 | 000 |
| 18906067662375 | K210103 | 000 |
| 18906067662412 | K210103 | 000 |
| 18906067662405 | K210103 | 000 |
| 18906067662368 | K210103 | 000 |
| 18906067662078 | K210103 | 000 |
| 18906067661941 | K210103 | 000 |