The following data is part of a premarket notification filed by Tuttnauer Co. Ltd. with the FDA for Tuttnauer Pre-vacuum Autoclave.
| Device ID | K850264 |
| 510k Number | K850264 |
| Device Name: | TUTTNAUER PRE-VACUUM AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER CO. LTD. P.O. BOX 909 Jerusalem, IL |
| Contact | Reuben Margoliash |
| Correspondent | Reuben Margoliash TUTTNAUER CO. LTD. P.O. BOX 909 Jerusalem, IL |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-06-04 |