The following data is part of a premarket notification filed by Kavo America with the FDA for Kavoklave Steam Autoclave.
| Device ID | K910789 |
| 510k Number | K910789 |
| Device Name: | KAVOKLAVE STEAM AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | KAVO AMERICA 1730 PENNSYLVANIA AVENUE N.W, Washington, DC 20006 |
| Contact | Chris Thomas |
| Correspondent | Chris Thomas KAVO AMERICA 1730 PENNSYLVANIA AVENUE N.W, Washington, DC 20006 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-25 |
| Decision Date | 1991-08-26 |