The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Tuttnauer Prevacuum Table Autoclave.
| Device ID | K962282 |
| 510k Number | K962282 |
| Device Name: | TUTTNAUER PREVACUUM TABLE AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER USA CO. LTD. 33 COMAC LOOP, EQUI-PARK Ronkonkoma, NY 11779 |
| Contact | Robert R Basile |
| Correspondent | Robert R Basile TUTTNAUER USA CO. LTD. 33 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 | 1996-06-12 |
| Decision Date | 1997-11-12 |
| Summary: | summary |