The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Securline Fine Needle Aspiration Biopsy Tray.
| Device ID | K874665 |
| 510k Number | K874665 |
| Device Name: | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY |
| Classification | Tray, Surgical |
| 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 | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-13 |
| Decision Date | 1988-01-20 |