The following data is part of a premarket notification filed by Haywood Vocational Opportunities with the FDA for Hvo, Inc., Disposable Non-sterile Surgical Drapes.
| Device ID | K050508 |
| 510k Number | K050508 |
| Device Name: | HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | HAYWOOD VOCATIONAL OPPORTUNITIES 56 SCATES ST. Waynesville, NC 28786 |
| Contact | Tim Kelley |
| Correspondent | Tim Kelley HAYWOOD VOCATIONAL OPPORTUNITIES 56 SCATES ST. Waynesville, NC 28786 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-04-27 |
| Summary: | summary |