The following data is part of a premarket notification filed by Or Specific, Inc. with the FDA for Or Specific Big Case Back Table Cover.
| Device ID | K052668 |
| 510k Number | K052668 |
| Device Name: | OR SPECIFIC BIG CASE BACK TABLE COVER |
| Classification | Drape, Surgical |
| Applicant | OR SPECIFIC, INC. 4651 36TH ST. #500 Orlando, FL 32811 |
| Contact | Daniel Becker |
| Correspondent | Daniel Becker OR SPECIFIC, INC. 4651 36TH ST. #500 Orlando, FL 32811 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-27 |
| Decision Date | 2006-07-24 |
| Summary: | summary |