The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Sky Bone Expander System.
| Device ID | K034037 |
| 510k Number | K034037 |
| Device Name: | SKY BONE EXPANDER SYSTEM |
| Classification | Arthroscope |
| Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahn |
| Correspondent | Jonathan S Kahn DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2004-01-28 |
| Summary: | summary |