FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GC ORAL MOISTURIZING GEL
K Number: K101346
·
Decision Jan 27, 2011
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
127
Review Days
259
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Basic Information
- Device Name
- GC ORAL MOISTURIZING GEL
- K Number
- K101346
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GC America, Inc.
- Date Received
- May 13, 2010
- Decision Date
- January 27, 2011
- Product Code
- LFD
- 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 |
|---|---|---|---|
| LFD | Saliva, Artificial | FDA unclassified | Unknown |
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