The following data is part of a premarket notification filed by Equi-tron Mfg., Inc. with the FDA for Equi-guard (aspirator Filter).
| Device ID | K902089 |
| 510k Number | K902089 |
| Device Name: | EQUI-GUARD (ASPIRATOR FILTER) |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | EQUI-TRON MFG., INC. 4600 WITMER INDUSTRIAL ESTATES Niagara Falls, NY 14305 |
| Contact | John Porter |
| Correspondent | John Porter EQUI-TRON MFG., INC. 4600 WITMER INDUSTRIAL ESTATES Niagara Falls, NY 14305 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-09 |
| Decision Date | 1990-07-06 |