HYDROPHILIC COATED GUIDEWIRE— 510(k) K981667
Substantially EquivalentLake Region Mfg., Inc.
FDA 510(k) clearance K981667 for HYDROPHILIC COATED GUIDEWIRE, Substantially Equivalent on 1998-06-05. Applicant: Lake Region Mfg., Inc.. Device class: 2.
Clearance details
- Applicant
- Lake Region Mfg., Inc.
- Product code
- Code KNY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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