Clearance Summary
WA-2000 TEMPERATURE INDICATOR received FDA 510(k) clearance under submission number K813402, sponsored by Wallach Surgical Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1982-01-12.
- Submission: K813402
- Applicant / Sponsor: Wallach Surgical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1982-01-12
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.