MCGHAN TISSUE EXPANDER FILL KIT— 510(k) K853014
Substantially EquivalentMcghan Medical Corp.
FDA 510(k) clearance K853014 for MCGHAN TISSUE EXPANDER FILL KIT, Substantially Equivalent on 1985-09-18. Applicant: Mcghan Medical Corp.. Device class: Unclassified.
Clearance details
- Applicant
- Mcghan Medical Corp.
- Product code
- Code LCJ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Barbara, CA, US
Recent devices under product code LCJ
view allMore clearances from Mcghan Medical Corp.
view allAdverse events under product code LCJ
product code LCJ- Injury
- 2,704
- Other
- 2
- Total
- 2,706
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 →
Recalls naming K853014
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K853014.
Data sourced from openFDA. This site is unofficial and independent of the FDA.