The following data is part of a premarket notification filed by Proact, Ltd. with the FDA for Proact Biopsy Needle Enchancements.
| Device ID | K926559 |
| 510k Number | K926559 |
| Device Name: | PROACT BIOPSY NEEDLE ENCHANCEMENTS |
| Classification | Biopsy Needle |
| Applicant | PROACT, LTD. CALDER SQUARE BOX 11029 State College, PA 16805 |
| Contact | Allan Darr |
| Correspondent | Allan Darr PROACT, LTD. CALDER SQUARE BOX 11029 State College, PA 16805 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-31 |
| Decision Date | 1993-03-22 |