The following data is part of a premarket notification filed by Comfort And Flexible Systems with the FDA for Cfs Flexible.
| Device ID | K081537 |
| 510k Number | K081537 |
| Device Name: | CFS FLEXIBLE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | COMFORT AND FLEXIBLE SYSTEMS 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour COMFORT AND FLEXIBLE SYSTEMS 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2009-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8422211061 | K081537 | 000 |