KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS— 510(k) K030788
Substantially EquivalentGeister Medizin Technik GmbH
FDA 510(k) clearance K030788 for KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS, Substantially Equivalent on 2003-07-12. Applicant: Geister Medizin Technik GmbH. Device class: 2.
Clearance details
- Applicant
- Geister Medizin Technik GmbH
- Product code
- Code DWP
- Device class
- Class 2
- Regulation
- 21 CFR 870.4475
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amsterdam, Nh, NL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.