510(k) K834558
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