K960552 is an FDA 510(k) clearance for the KNIGHT LIGHT NONLUBRICATED CONDOM. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Global Protection Corp. (Princeton, US). The FDA issued a Cleared decision on November 20, 1997, 651 days after receiving the submission on February 8, 1996.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K960552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1996 |
| Decision Date | November 20, 1997 |
| Days to Decision | 651 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIS - Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |