K960624 is an FDA 510(k) clearance for the CERTI COOL INSTANT COLD COMPRESS. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on May 6, 1996, 83 days after receiving the submission on February 13, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K960624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 13, 1996 |
| Decision Date | May 06, 1996 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |