The following data is part of a premarket notification filed by Tuttnauer Co. Ltd. with the FDA for American Gold Series Autoclave.
| Device ID | K833837 |
| 510k Number | K833837 |
| Device Name: | AMERICAN GOLD SERIES AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER CO. LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-03 |
| Decision Date | 1984-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110640088 | K833837 | 000 |
| 07290110640071 | K833837 | 000 |
| 07290110640064 | K833837 | 000 |
| 07290110640057 | K833837 | 000 |
| 07290110640637 | K833837 | 000 |