K113689 is an FDA 510(k) clearance for the DUKAL LUBRICATING JELLY. This device is classified as a Lubricant, Patient (Class I - General Controls, product code KMJ).
Submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on May 4, 2012, 141 days after receiving the submission on December 15, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.
| 510(k) Number | K113689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2011 |
| Decision Date | May 04, 2012 |
| Days to Decision | 141 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 |