510(k) K872045

CONDUCTIVITY GEL by Futuremed Div. of Future Impex Corp. — Product Code GYB

K872045 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "CONDUCTIVITY GEL". The FDA issued a decision of Substantially Equivalent on July 15, 1987. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1987
Date Received
May 27, 1987
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