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 |