The following data is part of a premarket notification filed by O.r. Solutions, Inc. with the FDA for Ors Model 6000 Endoscope Holder.
| Device ID | K051979 |
| 510k Number | K051979 |
| Device Name: | ORS MODEL 6000 ENDOSCOPE HOLDER |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | O.R. SOLUTIONS, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith O.R. SOLUTIONS, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-21 |
| Decision Date | 2005-08-30 |
| Summary: | summary |