K963596 is an FDA 510(k) clearance for the POLAR CARE 300. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on December 4, 1996, 86 days after receiving the submission on September 9, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K963596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1996 |
| Decision Date | December 04, 1996 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |