The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Touchless Ii Intermittent Catheter.
| Device ID | K910653 |
| 510k Number | K910653 |
| Device Name: | TOUCHLESS II INTERMITTENT CATHETER |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | C.R. BARD, INC. 111 SPRING ST. Murray Hill, NJ 07974 |
| Contact | John Hoffer |
| Correspondent | John Hoffer C.R. BARD, INC. 111 SPRING ST. Murray Hill, NJ 07974 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-14 |
| Decision Date | 1991-05-06 |