The following data is part of a premarket notification filed by Tuttnauer Co. Ltd. with the FDA for Tuttnauer Lsi (automatic).
| Device ID | K920478 |
| 510k Number | K920478 |
| Device Name: | TUTTNAUER LSI (AUTOMATIC) |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER CO. LTD. ONE COMAC LOOP EQUI-PARK Ronkonkoma, NY 11779 |
| Contact | Robert R Basile |
| Correspondent | Robert R Basile TUTTNAUER CO. LTD. ONE COMAC LOOP EQUI-PARK Ronkonkoma, NY 11779 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-29 |
| Decision Date | 1993-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110640170 | K920478 | 000 |
| 07290110640163 | K920478 | 000 |
| 07290110640156 | K920478 | 000 |
| 07290110640149 | K920478 | 000 |
| 07290110640132 | K920478 | 000 |
| 07290110640125 | K920478 | 000 |
| 07290110640095 | K920478 | 000 |