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FDA 510(k), K111622, UNIMAX ANTI-FOG SOLUTION
FDA 510(k), K111622, UNIMAX ANTI-FOG SOLUTION
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510(K) Number: K111622
Device Name: UNIMAX ANTI-FOG SOLUTION
Manufacturer: UNIMAX MEDICAL SYSTEMS, INC.
Device Classification Name: anti fog solution and accessories, endoscopy
Regulation Number: 876.1500
Classification Product Code: OCT
Date Received: 06/10/2011
Decision Date: 09/09/2011
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: UNIMAX ANTI-FOG SOLUTION
Manufacturer: UNIMAX MEDICAL SYSTEMS, INC.
Device Classification Name: anti fog solution and accessories, endoscopy
Regulation Number: 876.1500
Classification Product Code: OCT
Date Received: 06/10/2011
Decision Date: 09/09/2011
Regulation Medical Specialty: Gastroenterology/Urology
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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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