The following data is part of a premarket notification filed by Medical Measurements, Inc. with the FDA for Model Tr Rectal Suction Biopsy Tube.
| Device ID | K902097 |
| 510k Number | K902097 |
| Device Name: | MODEL TR RECTAL SUCTION BIOPSY TUBE |
| Classification | Instrument, Biopsy, Suction |
| Applicant | MEDICAL MEASUREMENTS, INC. 53 MAIN ST. Hackensack, NJ 07601 |
| Contact | William Sones |
| Correspondent | William Sones MEDICAL MEASUREMENTS, INC. 53 MAIN ST. Hackensack, NJ 07601 |
| Product Code | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-08 |
| Decision Date | 1990-07-27 |