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FDA 510(k), K082470, SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
FDA 510(k), K082470, SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
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510(K) Number: K082470
Device Name: SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
Manufacturer: GEORGE HORVAT
Device Classification Name: Cleanser, Root Canal
Regulation Number: KJJ
Classification Product Code: 08/27/2008
Date Received: 04/03/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
Manufacturer: GEORGE HORVAT
Device Classification Name: Cleanser, Root Canal
Regulation Number: KJJ
Classification Product Code: 08/27/2008
Date Received: 04/03/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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