BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE— 510(k) K984168
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K984168 for BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE, Substantially Equivalent on 1999-12-07. Applicant: United States Endoscopy Group, Inc.. Device class: 2.
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- Code FCF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code FCF
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