The following data is part of a premarket notification filed by Mitron Technologies, Inc. with the FDA for Cleanflow System.
| Device ID | K910728 |
| 510k Number | K910728 |
| Device Name: | CLEANFLOW SYSTEM |
| Classification | Evacuator, Gastro-urology |
| Applicant | MITRON TECHNOLOGIES, INC. 514 HARTFORD TURNPIKE P.O. BOX 776 Dayville, CT 06241 |
| Contact | Gene Zamba |
| Correspondent | Gene Zamba MITRON TECHNOLOGIES, INC. 514 HARTFORD TURNPIKE P.O. BOX 776 Dayville, CT 06241 |
| Product Code | KQT |
| CFR Regulation Number | 876.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-20 |
| Decision Date | 1991-04-01 |