The following data is part of a premarket notification filed by Scican Ltd. with the FDA for E-statis 40 System.
| Device ID | K090937 |
| 510k Number | K090937 |
| Device Name: | E-STATIS 40 SYSTEM |
| Classification | Controller, Foot, Handpiece And Cord |
| 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 | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-03 |
| Decision Date | 2009-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7022688800 | K090937 | 000 |
| D7022654640 | K090937 | 000 |
| D702265463 | K090937 | 000 |
| D7022654610 | K090937 | 000 |
| 10194665007188 | K090937 | 000 |
| 10194665007171 | K090937 | 000 |
| 10194665007164 | K090937 | 000 |