The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Franzen Needle Guide For Transrectal Prostate Biop.
| Device ID | K851364 |
| 510k Number | K851364 |
| Device Name: | FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP |
| Classification | Instrument, Biopsy |
| Applicant | PRECISION DYNAMICS CORP. 3031 THORNTON AVE. Burbank, CA 91504 |
| Contact | David L King |
| Correspondent | David L King PRECISION DYNAMICS CORP. 3031 THORNTON AVE. Burbank, CA 91504 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-04-22 |