The following data is part of a premarket notification filed by Holopack International, Lp with the FDA for Sodium Chloride Inhalation Solution, Usp.
| Device ID | K972466 |
| 510k Number | K972466 |
| Device Name: | SODIUM CHLORIDE INHALATION SOLUTION, USP |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HOLOPACK INTERNATIONAL, LP 1 TECHNOLOGY CIRCLE Columbia,, SC 29203 |
| Contact | John J Barthe |
| Correspondent | John J Barthe HOLOPACK INTERNATIONAL, LP 1 TECHNOLOGY CIRCLE Columbia,, SC 29203 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-08-28 |
| Summary: | summary |