PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS— 510(k) K081720
Substantially EquivalentPrime Herbs Corporation
FDA 510(k) clearance K081720 for PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS, Substantially Equivalent on 2009-06-16. Applicant: Prime Herbs Corporation. Device class: 2.
Clearance details
- Applicant
- Prime Herbs Corporation
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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More clearances from Prime Herbs Corporation
view allAdverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
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.