The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Dynacor Lubrication Gel.
| Device ID | K103718 |
| 510k Number | K103718 |
| Device Name: | DYNACOR LUBRICATION GEL |
| Classification | Lubricant, Patient |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-21 |
| Decision Date | 2011-05-10 |