IRRIGATION/ASPIRATION TUBING SET— 510(k) K911324
Substantially EquivalentBiomedical Dynamics, Inc.
FDA 510(k) clearance K911324 for IRRIGATION/ASPIRATION TUBING SET, Substantially Equivalent on 1991-06-24. Applicant: Biomedical Dynamics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomedical Dynamics, Inc.
- Product code
- Code KDH
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
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