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FDA 510(k), K090070, INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
FDA 510(k), K090070, INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
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510(K) Number: K090070
Device Name: INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
Manufacturer: KIT CARIQUITAN
Device Classification Name: Light, Surgical, Fiberoptic
Regulation Number: FST
Classification Product Code: KXA
Date Received: 01/12/2009
Decision Date: 04/22/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
Manufacturer: KIT CARIQUITAN
Device Classification Name: Light, Surgical, Fiberoptic
Regulation Number: FST
Classification Product Code: KXA
Date Received: 01/12/2009
Decision Date: 04/22/2009
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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