CERTI COOL INSTANT COLD COMPRESS— 510(k) K960624
Substantially Equivalent for Some IndicationsCertified Safety Mfg., Inc.
FDA 510(k) clearance K960624 for CERTI COOL INSTANT COLD COMPRESS, Substantially Equivalent for Some Indications on 1996-05-06. Applicant: Certified Safety Mfg., Inc..
Clearance details
- Applicant
- Certified Safety Mfg., Inc.
- Product code
- Code IMD
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Kansas City, MO, US
Adverse events under product code IMD
product code IMD- Death
- 3
- Injury
- 600
- Total
- 603
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.