The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Measured Volume Solution Administration Set.
| Device ID | K940054 |
| 510k Number | K940054 |
| Device Name: | MEASURED VOLUME SOLUTION ADMINISTRATION SET |
| 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 | 1994-01-05 |
| Decision Date | 1994-04-15 |