KPE PLUS-PAK SURGICAL SYSTEM— 510(k) K833962
Substantially EquivalentIpax, Inc.
FDA 510(k) clearance K833962 for KPE PLUS-PAK SURGICAL SYSTEM, Substantially Equivalent on 1984-03-12. Applicant: Ipax, Inc.. Device class: 2.
Clearance details
- Applicant
- Ipax, Inc.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Ipax, Inc.
view allAdverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.