ERCO-RIBBON— 510(k) K972353
Substantially EquivalentErcons, Inc.
FDA 510(k) clearance K972353 for ERCO-RIBBON, Substantially Equivalent on 1997-10-28. Applicant: Ercons, Inc.. Device class: 2.
Clearance details
- Applicant
- Ercons, Inc.
- Product code
- Code LKY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5020
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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