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FDA 510(k), K083452, ERBE MODEL VIO 300 D WITH ACCESSORIES
FDA 510(k), K083452, ERBE MODEL VIO 300 D WITH ACCESSORIES
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510(K) Number: K083452
Device Name: ERBE MODEL VIO 300 D WITH ACCESSORIES
Manufacturer: JULIE STEPHENS
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 11/21/2008
Decision Date: 12/31/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ERBE MODEL VIO 300 D WITH ACCESSORIES
Manufacturer: JULIE STEPHENS
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 11/21/2008
Decision Date: 12/31/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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