The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Extension Tube, Extension Tube Length 20, & 30.
| Device ID | K940073 |
| 510k Number | K940073 |
| Device Name: | EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30 |
| 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 | 1994-01-06 |
| Decision Date | 1994-03-23 |