510(k) K912075

C-SECTION TRAY by Medical Device Inspection Co., Inc. — Product Code KNA

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