510(k) K942000
K942000 is an FDA 510(k) premarket notification submitted by Medcare Custom Packaging, Inc. for the device "BURN DRESSING TRAY". The FDA issued a decision of Substantially Equivalent (kit) on May 20, 1994. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Medcare Custom Packaging, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- May 20, 1994
- Date Received
- April 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrap, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type