The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Securline Franseene Needle.
| Device ID | K873369 |
| 510k Number | K873369 |
| Device Name: | SECURLINE FRANSEENE NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
| Contact | Gino Franco |
| Correspondent | Gino Franco PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-21 |
| Decision Date | 1987-10-20 |