The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for B-twin Bone Expander System (b-twin Be System).
Device ID | K032358 |
510k Number | K032358 |
Device Name: | B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) |
Classification | Arthroscope |
Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
Contact | Jonanthan S Kahn |
Correspondent | Jonanthan 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-30 |
Decision Date | 2003-12-17 |
Summary: | summary |