510(k) K923627— COLD PACK
Substantially EquivalentFriendmed Products
Clearance details
- Applicant
- Friendmed Products
- Product code
- Code IME
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, PA, US
Adverse events under product code IME
product code IME- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.