JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
Device Facts
| Record ID | K952350 |
|---|---|
| Device Name | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) |
| Applicant | Promedical , Ltd. |
| Product Code | LWE · HO |
| Decision Date | Jul 17, 1995 |
| 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.
