Clearance Summary
ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL received FDA 510(k) clearance under submission number K842953, sponsored by All-Hands Medical Supply, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1984-08-21.
- Submission: K842953
- Applicant / Sponsor: All-Hands Medical Supply, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1984-08-21
Classification & Regulation
This clearance is catalogued under FDA product code HRR and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.