510(k) K912075
K912075 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "C-SECTION TRAY". The FDA issued a decision of Substantially Equivalent (kit) on April 7, 1992. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 7, 1992
- Date Received
- May 10, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Specialized Obstetric-Gynecologic
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type