PALEX (R) OSTOMY— 510(k) K871628
Substantially EquivalentIndustrias Palex C/O Dma Med-Chem Corp.
FDA 510(k) clearance K871628 for PALEX (R) OSTOMY, Substantially Equivalent on 1987-07-08. Applicant: Industrias Palex C/O Dma Med-Chem Corp..
Clearance details
- Applicant
- Industrias Palex C/O Dma Med-Chem Corp.
- Product code
- Code EXB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Adverse events under product code EXB
product code EXB- Injury
- 145
- Total
- 145
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.