510(k) K864124

SPAND-GEL GRANULATED GEL by Medi-Tech Intl. Corp. — Product Code KMF

K864124 is an FDA 510(k) premarket notification submitted by Medi-Tech Intl. Corp. for the device "SPAND-GEL GRANULATED GEL". The FDA issued a decision of SN on November 26, 1986. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Medi-Tech Intl. Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 26, 1986
Date Received
October 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type