510(k) K834558

CK10000 SERIES POUCH & BAGS ETC. by Currie Medical Specialties, Inc. — Product Code KCT

K834558 is an FDA 510(k) premarket notification submitted by Currie Medical Specialties, Inc. for the device "CK10000 SERIES POUCH & BAGS ETC.". The FDA issued a decision of Substantially Equivalent on September 5, 1984. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Currie Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1984
Date Received
December 28, 1983
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