GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020— 510(k) K083471
Substantially EquivalentGeneric Medical Device, Inc.
FDA 510(k) clearance K083471 for GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020, Substantially Equivalent on 2009-03-03. Applicant: Generic Medical Device, Inc..
Clearance details
- Applicant
- Generic Medical Device, Inc.
- Product code
- Code OTN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gig Harbor, WA, US
Adverse events under product code OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
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.