The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Visiclear Smoke Evacuation System.
| Device ID | K131402 |
| 510k Number | K131402 |
| Device Name: | VISICLEAR SMOKE EVACUATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | BUFFALO FILTER CO., INC. 5900 GENESEE STREET Lancaster, NY 14086 |
| Contact | Carrie Termin |
| Correspondent | Carrie Termin BUFFALO FILTER CO., INC. 5900 GENESEE STREET Lancaster, NY 14086 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2014-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995150129 | K131402 | 000 |