Clearance Summary
ISO-CARE KIT received FDA 510(k) clearance under submission number K781539, sponsored by Nice-Pak Products, 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 1978-11-03.
- Submission: K781539
- Applicant / Sponsor: Nice-Pak Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4440
- Decision date: 1978-11-03
Classification & Regulation
This clearance is catalogued under FDA product code HMP and 21 CFR 878.4440, within the General, Plastic Surgery review panel as a Class I device.