The following data is part of a premarket notification filed by Harmac Medical Products, Inc. with the FDA for Harmac Huber Needle Safety Device, H2984001.
| Device ID | K021916 |
| 510k Number | K021916 |
| Device Name: | HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 |
| Classification | Set, Administration, Intravascular |
| Applicant | HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Contact | Robert F Moran |
| Correspondent | Robert F Moran HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Product Code | FPA |
| Subsequent Product Code | FMI |
| Subsequent Product Code | LJT |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-11 |
| Decision Date | 2002-08-29 |
| Summary: | summary |