The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Campypak Plus W/palladium Catalyst Dispos. Hydroge.
| Device ID | K844571 |
| 510k Number | K844571 |
| Device Name: | CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE |
| Classification | Device, Gas Generating |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Contact | Russell J Arnsberge |
| Correspondent | Russell J Arnsberge BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | KZJ |
| CFR Regulation Number | 866.2580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-23 |
| Decision Date | 1985-01-30 |