The following data is part of a premarket notification filed by National Medical Products, Inc. with the FDA for J-tip Injector.
| Device ID | K973254 |
| 510k Number | K973254 |
| Device Name: | J-TIP INJECTOR |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | NATIONAL MEDICAL PRODUCTS, INC. 57 PARKER ST. Irvine, CA 92718 |
| Contact | Danny Patel |
| Correspondent | Danny 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 | 1997-08-29 |
| Decision Date | 1997-11-24 |