The following data is part of a premarket notification filed by Tuttnauer Co. Ltd. with the FDA for Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 Sp-1a, 66120 Sp-1a, 69150 Sp-2a, 69120 L Usa Sp-2a, 69180 Sp-2ha.
| Device ID | K063711 |
| 510k Number | K063711 |
| Device Name: | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER CO. LTD. 1776 K ST. N.W. SUITE 300 Washington, DC 20006 -2365 |
| Contact | Mark Yacura |
| Correspondent | Mark Yacura TUTTNAUER CO. LTD. 1776 K ST. N.W. SUITE 300 Washington, DC 20006 -2365 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-14 |
| Decision Date | 2007-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00729011064035 | K063711 | 000 |
| 07290110640422 | K063711 | 000 |
| 07290110640255 | K063711 | 000 |
| 07290110640262 | K063711 | 000 |
| 07290110640279 | K063711 | 000 |
| 07290110640286 | K063711 | 000 |
| 07290110640293 | K063711 | 000 |
| 07290110640309 | K063711 | 000 |
| 07290110640316 | K063711 | 000 |
| 07290110640323 | K063711 | 000 |
| 07290110640330 | K063711 | 000 |
| 07290110640347 | K063711 | 000 |
| 07290110640354 | K063711 | 000 |
| 07290110640361 | K063711 | 000 |
| 07290110640378 | K063711 | 000 |
| 07290110640385 | K063711 | 000 |
| 07290110640392 | K063711 | 000 |
| 07290110640408 | K063711 | 000 |