510(k) K912322
K912322 is an FDA 510(k) premarket notification submitted by Mega Medical, Inc. for the device "MEGA SPINAL ANESTHESIA KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on September 26, 1991. The device falls under product code CAZ (Anesthesia Conduction Kit), a Class II device regulated under 21 CFR 868.5140. Mega Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- September 26, 1991
- Date Received
- May 24, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anesthesia Conduction Kit
- Device Class
- Class II
- Regulation Number
- 868.5140
- Review Panel
- AN
- Submission Type
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.