The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Sigma 1 Wobbler Biopsy Kit.
| Device ID | K882673 |
| 510k Number | K882673 |
| Device Name: | SIGMA 1 WOBBLER BIOPSY KIT |
| Classification | Tray, Biopsy, Without Biopsy Instruments |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | David Cromwick |
| Correspondent | David Cromwick KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | FCH |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-28 |
| Decision Date | 1988-07-28 |