Clearance Summary
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR received FDA 510(k) clearance under submission number K981602, sponsored by Sunrise Medical Hhg, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1998-07-17.
- Submission: K981602
- Applicant / Sponsor: Sunrise Medical Hhg, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1998-07-17
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.