COLORPLAST TRANSVERSE SYSTEM— 510(k) K771775
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K771775 for COLORPLAST TRANSVERSE SYSTEM, Substantially Equivalent on 1977-09-30. Applicant: C.R. Bard, Inc.. Device class: 1.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code EXB
- Device class
- Class 1
- Regulation
- 21 CFR 876.5900
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code EXB
product code EXB- Injury
- 145
- Total
- 145
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.