Clearance Summary
VAGINAL ILLUMINATOR, MODEL 78570 received FDA 510(k) clearance under submission number K771181, sponsored by Welch Allyn, 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 1977-07-14.
- Submission: K771181
- Applicant / Sponsor: Welch Allyn, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1977-07-14
Classification & Regulation
This clearance is catalogued under FDA product code HDG and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.