The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Quadrasorb Filter.
| Device ID | K923661 |
| 510k Number | K923661 |
| Device Name: | QUADRASORB FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. P.O. BOX 508 ABERDEEN ROAD Emigsville, PA 17318 |
| Contact | Lonnie M Graybill |
| Correspondent | Lonnie M Graybill UNION BROACH, DIV. MOYCO INDUSTRIES, INC. P.O. BOX 508 ABERDEEN ROAD Emigsville, PA 17318 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-22 |
| Decision Date | 1992-10-20 |