Clearance Summary
C-SECTION PACK received FDA 510(k) clearance under submission number K921730, sponsored by Medikmark, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1994-06-15.
- Submission: K921730
- Applicant / Sponsor: Medikmark, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1994-06-15
Classification & Regulation
This clearance is catalogued under FDA product code KOH and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.