The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Suction Biopsy Instrument.
| Device ID | K895420 |
| 510k Number | K895420 |
| Device Name: | SUCTION BIOPSY INSTRUMENT |
| Classification | Instrument, Biopsy, Suction |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Mark Kozak |
| Correspondent | Mark Kozak MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-01 |
| Decision Date | 1990-02-09 |