Clearance Summary
ROCKET SEX CRIME KIT received FDA 510(k) clearance under submission number K883805, sponsored by A & A Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1989-01-31.
- Submission: K883805
- Applicant / Sponsor: A & A Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1989-01-31
Classification & Regulation
This clearance is catalogued under FDA product code FMC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.