The following data is part of a premarket notification filed by Paco Pharmaceutical Services, Inc. with the FDA for Sterile Saline Solution.
| Device ID | K843797 |
| 510k Number | K843797 |
| Device Name: | STERILE SALINE SOLUTION |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | PACO PHARMACEUTICAL SERVICES, INC. 1200 PACO WAY BUILDING 19 Lakewood, NJ 08701 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1985-01-18 |