The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Horizon Foley Catheterization Tray Without Catheter.
| Device ID | K950344 |
| 510k Number | K950344 |
| Device Name: | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
| Contact | Ben Walthall |
| Correspondent | Ben Walthall ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-03-24 |