The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for -om West 2000 Gnatus Chair.
| Device ID | K863008 |
| 510k Number | K863008 |
| Device Name: | -OM WEST 2000 GNATUS CHAIR |
| Classification | Chair, Ophthalmic, Ac-powered |
| 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 | HME |
| CFR Regulation Number | 886.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-08 |
| Decision Date | 1986-09-24 |