K926590 is an FDA 510(k) clearance for the ANAGO DISPOSABLE INSTANT COLD PACK. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 26, 1993, 170 days after receiving the submission on December 7, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K926590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1992 |
| Decision Date | May 26, 1993 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |