The following data is part of a premarket notification filed by Lb Medical L.l.c. with the FDA for Lb Medical Inflatable Tissue Elevator/expander System.
| Device ID | K080158 |
| 510k Number | K080158 |
| Device Name: | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM |
| Classification | Expander, Skin, Inflatable |
| Applicant | LB MEDICAL L.L.C. 901 KING STREET, SUITE 200 Alexandria, VA 22314 |
| Contact | Terry Sheridan Powell |
| Correspondent | Terry Sheridan Powell LB MEDICAL L.L.C. 901 KING STREET, SUITE 200 Alexandria, VA 22314 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-23 |
| Decision Date | 2008-05-02 |
| Summary: | summary |