The following data is part of a premarket notification filed by Pharmazeutische Fabrik Montavit Gmbh with the FDA for Cathejell S Sterile Lubricating Jelly.
| Device ID | K935548 |
| 510k Number | K935548 |
| Device Name: | CATHEJELL S STERILE LUBRICATING JELLY |
| Classification | Jelly, Lubricating, For Transurethral Surgical Instrument |
| Applicant | PHARMAZEUTISCHE FABRIK MONTAVIT GMBH CMR ASSOCIATES 372 DANBURY ROAD Wilton, CT 06897 |
| Contact | Henry S Perdue, Ph.d |
| Correspondent | Henry S Perdue, Ph.d PHARMAZEUTISCHE FABRIK MONTAVIT GMBH CMR ASSOCIATES 372 DANBURY ROAD Wilton, CT 06897 |
| Product Code | FHX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-17 |
| Decision Date | 1994-03-30 |