LOW PH PHENOLIC 256— 510(k) K983585
Substantially EquivalentCentral Solutions, Inc.
FDA 510(k) clearance K983585 for LOW PH PHENOLIC 256, Substantially Equivalent on 1998-11-06. Applicant: Central Solutions, Inc.. Device class: 1.
Clearance details
- Applicant
- Central Solutions, Inc.
- Product code
- Code LRJ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6890
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, KS, US
Recent devices under product code LRJ
view allMore clearances from Central Solutions, Inc.
view allAdverse events under product code LRJ
product code LRJ- Injury
- 958
- Total
- 958
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.