CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS— 510(k) K934610
Substantially EquivalentTabex Industries, Inc.
FDA 510(k) clearance K934610 for CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS, Substantially Equivalent on 1994-09-23. Applicant: Tabex Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Tabex Industries, Inc.
- Product code
- Code FJS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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- K120130 — FALLER TROCAR
More clearances from Tabex Industries, Inc.
view allAdverse events under product code FJS
product code FJS- Death
- 34
- Injury
- 652
- Malfunction
- 576
- Other
- 6
- Total
- 1,268
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.