510(k) K895819

MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL by Medi-Tech, Inc. — Product Code KMF

K895819 is an FDA 510(k) premarket notification submitted by Medi-Tech, Inc. for the device "MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL". The FDA issued a decision of SN on November 2, 1989. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Medi-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 2, 1989
Date Received
September 29, 1989
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