510(k) K022494

HOME CARE JELLY by Roc Chinese-European Industrial Research Society — Product Code GYB

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