The following data is part of a premarket notification filed by Bio-medical Devices, Inc. with the FDA for Maxi-flow Suction Tube/top Gun Suction Irrigator.
| Device ID | K955151 |
| 510k Number | K955151 |
| Device Name: | MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR |
| Classification | Tube, Aspirating, Flexible, Connecting |
| Applicant | BIO-MEDICAL DEVICES, INC. 1752-A LANGLEY AVE. Irvine, CA 92614 |
| Contact | Nick Herbert |
| Correspondent | Nick Herbert BIO-MEDICAL DEVICES, INC. 1752-A LANGLEY AVE. Irvine, CA 92614 |
| Product Code | BYY |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-01-24 |