Clearance Summary
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 received FDA 510(k) clearance under submission number K891998, sponsored by Elwyn Industries. 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 1989-06-05.
- Submission: K891998
- Applicant / Sponsor: Elwyn Industries
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 1989-06-05
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.