SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
FDA 510(k) clearance K082470 · decided 2009-04-03
Clearance details
- K-number
- K082470
- Device name
- SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
- Applicant
- Inter-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-27
- Decision date
- 2009-04-03
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- KJJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Racine, WI, US
- Third-party review
- No
- Expedited review
- No
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