The following data is part of a premarket notification filed by Patsy J. Trisler, J.d. with the FDA for Comfortcare System.
| Device ID | K933126 |
| 510k Number | K933126 |
| Device Name: | COMFORTCARE SYSTEM |
| Classification | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Applicant | PATSY J. TRISLER, J.D. 1700 ROCKVILLE PIKE SUITE 535 Rockville, MD 20852 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler PATSY J. TRISLER, J.D. 1700 ROCKVILLE PIKE SUITE 535 Rockville, MD 20852 |
| Product Code | EYZ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1994-02-25 |