SMARTVAC SMOKE EVACUATION SYSTEM— 510(k) K970352
Substantially EquivalentIsomedix Operations, Inc.
FDA 510(k) clearance K970352 for SMARTVAC SMOKE EVACUATION SYSTEM, Substantially Equivalent on 1997-11-04. Applicant: Isomedix Operations, Inc.. Device class: 2.
Clearance details
- Applicant
- Isomedix Operations, Inc.
- Product code
- Code FYD
- Device class
- Class 2
- Regulation
- 21 CFR 878.5070
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
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