The following data is part of a premarket notification filed by Avail Medical Products, Inc. with the FDA for Steri-lub Lubrication Gel.
| Device ID | K083189 |
| 510k Number | K083189 |
| Device Name: | STERI-LUB LUBRICATION GEL |
| Classification | Lubricant, Patient |
| Applicant | AVAIL MEDICAL PRODUCTS, INC. 1900 CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Patricia A Goeree |
| Correspondent | Patricia A Goeree AVAIL MEDICAL PRODUCTS, INC. 1900 CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-29 |
| Decision Date | 2008-11-21 |
| Summary: | summary |