ORIGINEEDLE(TM)— 510(k) K904849
Substantially EquivalentOrigin Medsystems, Inc.
FDA 510(k) clearance K904849 for ORIGINEEDLE(TM), Substantially Equivalent on 1991-03-29. Applicant: Origin Medsystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Origin Medsystems, Inc.
- Product code
- Code FHO
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Mateo, CA, US
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