VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520— 510(k) K022823
Substantially EquivalentGeister Medizin Technik GmbH
FDA 510(k) clearance K022823 for VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520, Substantially Equivalent on 2004-07-01. Applicant: Geister Medizin Technik GmbH. Device class: 2.
Clearance details
- Applicant
- Geister Medizin Technik GmbH
- Product code
- Code MGZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hot Springs, NC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.