Clearance Summary
BANDAGES, SPEC. X-TRA HARD OR PLASTER received FDA 510(k) clearance under submission number K770929, sponsored by Johnson & Johnson Professionals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1977-06-02.
- Submission: K770929
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1977-06-02
Classification & Regulation
This clearance is catalogued under FDA product code ITG and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.