SINUSCOPE AND ACCESSORIES— 510(k) K981751
Substantially EquivalentHenke Sass Wolf of America, Inc.
FDA 510(k) clearance K981751 for SINUSCOPE AND ACCESSORIES, Substantially Equivalent on 1998-08-13. Applicant: Henke Sass Wolf of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Henke Sass Wolf of America, Inc.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southbridge, MA, US
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Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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.