510(k) K941327

CROSSTEX SELF-SEALING STERILIZATION POUCH by Cross Country Paper Products Corp. — Product Code KCT

K941327 is an FDA 510(k) premarket notification submitted by Cross Country Paper Products Corp. for the device "CROSSTEX SELF-SEALING STERILIZATION POUCH". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Cross Country Paper Products Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
March 18, 1994
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