The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Bravo Autoclave, Models 17, 17v And 21v.
| Device ID | K090265 |
| 510k Number | K090265 |
| Device Name: | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V |
| Classification | Sterilizer, Steam |
| Applicant | SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Brenda Murphy |
| Correspondent | Brenda Murphy SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-03 |
| Decision Date | 2009-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540196002110 | K090265 | 000 |
| 07540196002103 | K090265 | 000 |
| 07540196002097 | K090265 | 000 |