CURITY PERINEAL COLD PACK
Device Facts
| Record ID | K810693 |
|---|---|
| Device Name | CURITY PERINEAL COLD PACK |
| Applicant | The Kendal Co. |
| Product Code | IMD · Physical Medicine |
| Decision Date | Mar 26, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.