The following data is part of a premarket notification filed by Amg Medical Equipments, Inc. with the FDA for Resu-gard Catheter Suction.
| Device ID | K902093 |
| 510k Number | K902093 |
| Device Name: | RESU-GARD CATHETER SUCTION |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | AMG MEDICAL EQUIPMENTS, INC. 743 MICHIGAN LN. Elk Grove, IL 60007 |
| Contact | Gajo, M.d. |
| Correspondent | Gajo, M.d. AMG MEDICAL EQUIPMENTS, INC. 743 MICHIGAN LN. Elk Grove, IL 60007 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-09 |
| Decision Date | 1990-10-23 |