K013614 is an FDA 510(k) clearance for the TROJAN CRYSTAL CLEAR LIQUID, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 1, 2002, 88 days after receiving the submission on November 5, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K013614 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 2001 |
| Decision Date | February 01, 2002 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NUC — Lubricant, Personal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
| Definition | This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. |