RELAX-O-GUARD— 510(k) K925064
Substantially Equivalent for Some IndicationsAquatemp Service Co., Inc.
FDA 510(k) clearance K925064 for RELAX-O-GUARD, Substantially Equivalent for Some Indications on 1993-09-13. Applicant: Aquatemp Service Co., Inc..
Clearance details
- Applicant
- Aquatemp Service Co., Inc.
- Product code
- Code KMY
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Morristown, NJ, US
Adverse events under product code KMY
product code KMY- Injury
- 1,457
- Total
- 1,457
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.