CUSTOM KWIK SET AND/OR PAK— 510(k) K832517
Substantially EquivalentNorton Texas Medical Products
FDA 510(k) clearance K832517 for CUSTOM KWIK SET AND/OR PAK, Substantially Equivalent on 1983-10-14. Applicant: Norton Texas Medical Products. Device class: 2.
Clearance details
- Applicant
- Norton Texas Medical Products
- Product code
- Code JOL
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JOL
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- K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
- K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
- K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
- K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
More clearances from Norton Texas Medical Products
view allAdverse events under product code JOL
product code JOL- Death
- 7
- Injury
- 177
- Malfunction
- 1,306
- Other
- 1
- Total
- 1,491
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.