K092488 is an FDA 510(k) clearance for the DYNAREX STERILE LUBRICATING JELLY. This device is classified as a Lubricant, Patient (Class I - General Controls, product code KMJ).
Submitted by Dynarex Corporation (Orangeburg, US). The FDA issued a Cleared decision on December 18, 2009, 127 days after receiving the submission on August 13, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.
| 510(k) Number | K092488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2009 |
| Decision Date | December 18, 2009 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KMJ — Lubricant, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6375 |