510(k) K954185

RE-BAG MULTI-USE POUCH, LARGE & SMALL by Miltex, Inc. — Product Code KCT

K954185 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "RE-BAG MULTI-USE POUCH, LARGE & SMALL". The FDA issued a decision of Substantially Equivalent - Kit on Dec 4, 1995. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Miltex, Inc. has 22 other 510(k) clearances on record.

Clearance details

Decision
SESK (Substantially Equivalent - Kit)
Decision Date
Dec 4, 1995
Date Received
Sep 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K954185. Report a data issue: hello@regdatalab.com.