The following data is part of a premarket notification filed by Carewell Mediproducts, Ltd. with the FDA for Careject Disposable Syringe And Needle.
| Device ID | K931472 |
| 510k Number | K931472 |
| Device Name: | CAREJECT DISPOSABLE SYRINGE AND NEEDLE |
| Classification | Syringe, Piston |
| Applicant | CAREWELL MEDIPRODUCTS, LTD. 502 MANSAROVAR, 90 NEHRU PL. New Delhi, IN 110019 |
| Contact | Nand |
| Correspondent | Nand CAREWELL MEDIPRODUCTS, LTD. 502 MANSAROVAR, 90 NEHRU PL. New Delhi, IN 110019 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-24 |
| Decision Date | 1994-02-22 |