K950395 is an FDA 510(k) clearance for the THERMOCOOL SYSTEM. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on August 18, 1995, 198 days after receiving the submission on February 1, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K950395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 01, 1995 |
| Decision Date | August 18, 1995 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |