FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
K Number: K082470
·
Decision Apr 3, 2009
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
8
Review Days
219
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Basic Information
- Device Name
- SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
- K Number
- K082470
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inter-Med, Inc.
- Date Received
- August 27, 2008
- Decision Date
- April 3, 2009
- Product Code
- KJJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | FDA unclassified | Unknown |
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