BONE-TEMNO/STERNUM-TEMNO
Device Facts
| Record ID | K913306 |
|---|---|
| Device Name | BONE-TEMNO/STERNUM-TEMNO |
| Applicant | Proact, Ltd. |
| Product Code | LWE · HO |
| Decision Date | Nov 1, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class 2 |
Regulatory Classification
Identification
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
