The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Gas Pak Ii Dis. Generator Envelopes.
| Device ID | K800796 |
| 510k Number | K800796 |
| Device Name: | GAS PAK II DIS. GENERATOR ENVELOPES |
| Classification | Device, Gas Generating |
| Applicant | 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 | 1980-04-09 |
| Decision Date | 1980-04-24 |