510(k) K022494
K022494 is an FDA 510(k) premarket notification submitted by Roc Chinese-European Industrial Research Society for the device "HOME CARE JELLY". The FDA issued a decision of Substantially Equivalent on December 2, 2002. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Roc Chinese-European Industrial Research Society has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2002
- Date Received
- July 29, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type