The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for F-11 Reflector / F-ii Standard Reflector.
| Device ID | K863019 |
| 510k Number | K863019 |
| Device Name: | F-11 REFLECTOR / F-II STANDARD REFLECTOR |
| Classification | Light, Operating, Dental |
| Applicant | SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington, DC 20016 |
| Contact | Cesar Coral |
| Correspondent | Cesar Coral SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington, DC 20016 |
| Product Code | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-08 |
| Decision Date | 1986-09-29 |