Clearance Summary
ICE-PAK, PDI received FDA 510(k) clearance under submission number K780279, sponsored by Nice-Pak Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1978-04-10.
- Submission: K780279
- Applicant / Sponsor: Nice-Pak Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 1978-04-10
Classification & Regulation
This clearance is catalogued under FDA product code IMD and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.