The following data is part of a premarket notification filed by Jianerkang Medical Dressing Company with the FDA for Sterile Lubricating Jelly.
| Device ID | K112110 |
| 510k Number | K112110 |
| Device Name: | STERILE LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | JIANERKANG MEDICAL DRESSING COMPANY ZHIXI TOWN Jintan City, Jiangsu, CN 213251 |
| Contact | Jordon Chu |
| Correspondent | Jordon Chu JIANERKANG MEDICAL DRESSING COMPANY ZHIXI TOWN Jintan City, Jiangsu, CN 213251 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2012-04-10 |
| Summary: | summary |