510(k) K922179
K922179 is an FDA 510(k) premarket notification submitted by Medcare Custom Packaging, Inc. for the device "CATHETER INSERTION TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 2, 1993. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Medcare Custom Packaging, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- July 2, 1993
- Date Received
- May 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type