K883805 is an FDA 510(k) clearance for the ROCKET SEX CRIME KIT. This device is classified as a Patient Examination Glove (Class I — General Controls, product code FMC).
Submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on January 31, 1989, 146 days after receiving the submission on September 7, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K883805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1988 |
| Decision Date | January 31, 1989 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMC — Patient Examination Glove |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |