510(k) K941327
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