The following data is part of a premarket notification filed by Triton Technology, Inc. with the FDA for Multiple Biopsy Device-mbx.
| Device ID | K911448 |
| 510k Number | K911448 |
| Device Name: | MULTIPLE BIOPSY DEVICE-MBX |
| Classification | Instrument, Biopsy, Suction |
| Applicant | TRITON TECHNOLOGY, INC. 2380 SOUTHEAST BLVD. Salem, OH 44460 |
| Contact | William Z Kolozsi |
| Correspondent | William Z Kolozsi TRITON TECHNOLOGY, INC. 2380 SOUTHEAST BLVD. Salem, OH 44460 |
| Product Code | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-15 |
| Decision Date | 1991-04-16 |