K820282 is an FDA 510(k) clearance for the ACE BRAND INSTANT COLD PACK. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on February 12, 1982, 10 days after receiving the submission on February 2, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K820282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1982 |
| Decision Date | February 12, 1982 |
| Days to Decision | 10 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 |