FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARK TONGUE CLEANER
K Number: K841077
·
Decision Jul 2, 1984
Classifications
1
FEI Numbers
150
Registration Numbers
151
Same Product Code
30
Applicant Total
2
Review Days
112
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Basic Information
- Device Name
- ARK TONGUE CLEANER
- K Number
- K841077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Arkay Co.
- Date Received
- March 12, 1984
- Decision Date
- July 2, 1984
- Product Code
- LCN
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| LCN | Scraper, Tongue | FDA class 1 | Dental |
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Other Clearances by Arkay Co.
| K Number | Device Name | ||
|---|---|---|---|
| K844291 | ARK TONGUE CLEANER | Nov 23, 1984 | Substantially Equivalent |