Clearance Summary
FORCEPS, OB, NON-COMPRESSIVE received FDA 510(k) clearance under submission number K771106, sponsored by Zeppelin Medizinlechnik GmbH. 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 1977-07-01.
- Submission: K771106
- Applicant / Sponsor: Zeppelin Medizinlechnik GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4400
- Decision date: 1977-07-01
Classification & Regulation
This clearance is catalogued under FDA product code HDA and 21 CFR 884.4400, within the Obstetrics/Gynecology review panel as a Class II device.