FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TONGUE SCRAPPER
K Number: K961574
·
Decision Jun 10, 1996
Classifications
1
FEI Numbers
150
Registration Numbers
151
Same Product Code
30
Applicant Total
4
Review Days
48
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Basic Information
- Device Name
- TONGUE SCRAPPER
- K Number
- K961574
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- U.S. Dentek Corp.
- Date Received
- April 23, 1996
- Decision Date
- June 10, 1996
- 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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