The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for 0.22 Micron Final Filter With Extension Tube.
| Device ID | K935601 |
| 510k Number | K935601 |
| Device Name: | 0.22 MICRON FINAL FILTER WITH EXTENSION TUBE |
| Classification | Set, Administration, Intravascular |
| Applicant | PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Contact | Thomas P Dimaio |
| Correspondent | Thomas P Dimaio PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-19 |
| Decision Date | 1994-01-21 |