510(k) K920339
K920339 is an FDA 510(k) premarket notification submitted by Medikmark, Inc. for the device "DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on April 23, 1992. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Medikmark, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- April 23, 1992
- Date Received
- January 24, 1992
- 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