K920760 is an FDA 510(k) clearance for the PERI-K PAD COLD PACK. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on July 29, 1993, 526 days after receiving the submission on February 19, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K920760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1992 |
| Decision Date | July 29, 1993 |
| Days to Decision | 526 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |