Clearance Summary
SHOVEL RETRACTOR received FDA 510(k) clearance under submission number K822109, sponsored by Bio-Blitz, 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 1982-07-30.
- Submission: K822109
- Applicant / Sponsor: Bio-Blitz, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1100
- Decision date: 1982-07-30
Classification & Regulation
This clearance is catalogued under FDA product code NBH and 21 CFR 888.1100, within the Orthopedic review panel as a Class I device.