The following data is part of a premarket notification filed by Continental Medical Laboratories, Inc. with the FDA for Urethral Catheterization Tray/universal Urethral Cath Tray.
| Device ID | K962073 |
| 510k Number | K962073 |
| Device Name: | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | CONTINENTAL MEDICAL LABORATORIES, INC. 817 W.MOHR AVE. P.O. BOX 306 Waterford, WI 53185 |
| Contact | Joseph Dunn |
| Correspondent | Joseph Dunn CONTINENTAL MEDICAL LABORATORIES, INC. 817 W.MOHR AVE. P.O. BOX 306 Waterford, WI 53185 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-06-21 |