TONGUE DEPRESSOR
FDA 510(k) clearance K842461 · decided 1984-11-30
Clearance details
- K-number
- K842461
- Device name
- TONGUE DEPRESSOR
- Applicant
- The Torrent Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-22
- Decision date
- 1984-11-30
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- FMA
- Device class
- 1
- Regulation number
- 880.6230
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AROMATIC AND FLAVORED TONGUE DEPRESSOR (K992995) | Aga Plastic Ind. Com. Ltda. | 1999-12-09 |
| MINI LANCET-BLOOD LANCET (K830705) | Pharmaquest Corp. | 1983-04-08 |
| BITE STICK (K821177) | Abco Dealers, Inc. | 1982-05-21 |
| MOUTH WASH TRAY (K770120) | Pharmaseal Div., Baxter Healthcare Corp. | 1977-01-28 |
Recalls involving this device
No recalls on record reference this clearance.