PELVX GELLHORN VAGINAL PESSARY 603-608— 510(k) K002329

Substantially Equivalent

Deschutes Medical Products, Inc.

FDA 510(k) clearance K002329 for PELVX GELLHORN VAGINAL PESSARY 603-608, Substantially Equivalent on 2000-09-18. Applicant: Deschutes Medical Products, Inc..

Clearance details

Applicant
Deschutes Medical Products, Inc.
Product code
Code HHW
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bend, OR, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HHW

product code HHW
Malfunction
485
Total
485

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.