The following data is part of a premarket notification filed by Harmac Medical Products, Inc. with the FDA for Harmac Extension Infusion Set.
| Device ID | K950895 |
| 510k Number | K950895 |
| Device Name: | HARMAC EXTENSION INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Contact | Joseph M Konieczny |
| Correspondent | Joseph M Konieczny HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-09-01 |