The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Tuttnauer Table-top Autoclave.
| Device ID | K973550 |
| 510k Number | K973550 |
| Device Name: | TUTTNAUER TABLE-TOP AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER USA CO. LTD. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
| Contact | Mark M Yacura |
| Correspondent | Mark M Yacura TUTTNAUER USA CO. LTD. 1333 NEW HAMPSHIRE AVE., N.W. SUITE 400 Washington, DC 20036 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1997-10-29 |
| Summary: | summary |