FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TONGUE DEPRESSOR
K Number: K842461
·
Decision Nov 30, 1984
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
4
Applicant Total
3
Review Days
161
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Basic Information
- Device Name
- TONGUE DEPRESSOR
- K Number
- K842461
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6230
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Torrent Corp.
- Date Received
- June 22, 1984
- Decision Date
- November 30, 1984
- Product Code
- FMA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMA | Depressor, Tongue, Non-Surgical | FDA class 1 | General Hospital |
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