K882413 is an FDA 510(k) clearance for the SUBOCCIPITAL ICE PILLOW. This device is classified as a Pack, Hot Or Cold, Reusable (Class I - General Controls, product code IME).
Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on November 30, 1988, 170 days after receiving the submission on June 13, 1988.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5700.
| 510(k) Number | K882413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1988 |
| Decision Date | November 30, 1988 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IME — Pack, Hot Or Cold, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5700 |