MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE— 510(k) K980016
Substantially EquivalentGenzyme Surgical Product (Genzyme Biosurgery)
FDA 510(k) clearance K980016 for MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE, Substantially Equivalent on 1998-08-07. Applicant: Genzyme Surgical Product (Genzyme Biosurgery). Device class: 1.
Clearance details
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Product code
- Code MOP
- Device class
- Class 1
- Regulation
- 21 CFR 870.3935
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.