510(k) K912661

MATRX, PYRAMID TRIANGLE BANDAGE by Matrix Medica, Inc. — Product Code ILI

K912661 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "MATRX, PYRAMID TRIANGLE BANDAGE". The FDA issued a decision of Substantially Equivalent on August 21, 1991. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1991
Date Received
June 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sling, Arm
Device Class
Class I
Regulation Number
890.3640
Review Panel
PM
Submission Type