The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Percutaneous Grainage Catheter.
| Device ID | K943893 |
| 510k Number | K943893 |
| Device Name: | PERCUTANEOUS GRAINAGE CATHETER |
| Classification | Catheter, Nephrostomy |
| Applicant | MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Contact | Bob Bley |
| Correspondent | Bob Bley MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-09 |
| Decision Date | 1995-03-07 |