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 |