K103718 is an FDA 510(k) clearance for the DYNACOR LUBRICATION GEL. This device is classified as a Lubricant, Patient (Class I - General Controls, product code KMJ).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 10, 2011, 140 days after receiving the submission on December 21, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.
| 510(k) Number | K103718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2010 |
| Decision Date | May 10, 2011 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KMJ — Lubricant, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6375 |