510(k) K850177

MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN) by Matrix Medica, Inc. — Product Code FYA

K850177 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)". The FDA issued a decision of Substantially Equivalent on February 21, 1985. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1985
Date Received
January 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type