The following data is part of a premarket notification filed by Horizon Medical, Inc. with the FDA for Steri-lub Lubrication Gel.
| Device ID | K944969 |
| 510k Number | K944969 |
| Device Name: | STERI-LUB LUBRICATION GEL |
| Classification | Lubricant, Patient |
| Applicant | HORIZON MEDICAL, INC. 1719 S. GRAND AVE. Santa Ana, CA 92705 -4808 |
| Contact | Phillip L Ritger |
| Correspondent | Phillip L Ritger HORIZON MEDICAL, INC. 1719 S. GRAND AVE. Santa Ana, CA 92705 -4808 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-11 |
| Decision Date | 1995-02-27 |