The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Porta Plumesafe(tm) 601 Smoke Evacuation System.
| Device ID | K924732 |
| 510k Number | K924732 |
| Device Name: | PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | BUFFALO FILTER CO., INC. 8388 BRIDLEWOOD DR. E. Amherst, NY 14051 |
| Contact | Clinton R Holland |
| Correspondent | Clinton R Holland BUFFALO FILTER CO., INC. 8388 BRIDLEWOOD DR. E. Amherst, NY 14051 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-22 |
| Decision Date | 1993-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995150044 | K924732 | 000 |
| 00724995150020 | K924732 | 000 |
| 20653405043529 | K924732 | 000 |
| 20653405043512 | K924732 | 000 |
| 20653405012495 | K924732 | 000 |
| 20653405012488 | K924732 | 000 |
| 10884521189669 | K924732 | 000 |