The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Sterile Urethral Catheter Procedure Kits.
| Device ID | K903340 |
| 510k Number | K903340 |
| Device Name: | STERILE URETHRAL CATHETER PROCEDURE KITS |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Maureen Mccabe |
| Correspondent | Maureen Mccabe SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-25 |
| Decision Date | 1990-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521009503 | K903340 | 000 |