The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Mon-a-therm Foley Kit.
| Device ID | K923538 |
| 510k Number | K923538 |
| Device Name: | MON-A-THERM FOLEY KIT |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Jeffery W Biggers |
| Correspondent | Jeffery W Biggers MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1993-05-27 |