The following data is part of a premarket notification filed by National Medical Products, Inc. with the FDA for J-tip Needless Injector.
| Device ID | K980082 |
| 510k Number | K980082 |
| Device Name: | J-TIP NEEDLESS INJECTOR |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | NATIONAL MEDICAL PRODUCTS, INC. 57 PARKER ST. Irvine, CA 92718 |
| Contact | Rohit Patel |
| Correspondent | Rohit Patel NATIONAL MEDICAL PRODUCTS, INC. 57 PARKER ST. Irvine, CA 92718 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-09 |
| Decision Date | 1998-03-04 |