LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.— 510(k) K960866
Substantially EquivalentLake Region Mfg., Inc.
FDA 510(k) clearance K960866 for LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS., Substantially Equivalent on 1996-04-05. 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
Recent devices under product code KNY
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