510(k) K842461
- Device
- Tongue Depressor
- Applicant
- THE TORRENT CORP.
- 510(k) number
- K842461
- Product code
- FMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-30
- Date received
- 1984-06-22
- Regulation
- 880.6230
- Classification name
- Depressor, Tongue, Non-Surgical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY L SWANSON
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3010055973
- 3010131137
- 2183301
- 3009148458
- 3008808049
- 3010374920
- 3010155661
- 3006411563
- 1032347
- 3045058049
- 3014652222
- 3031184338
- 3010872396
- 3021031939
- 3013735158
- 3009865268
- 1319130
- 3042896810
- 3005809810
- 3011669217
- 3021282544
- 3044150131
- 3017231740
- 3015337116
- 8043512
- 3015997711
- 9611959
- 8043769
- 3005739529
- 3011182134
- 3015058854
- 3003887292
- 3011983031
- 3023917
- 3031582434
- 3011529314
- 3008808560
- 3008280196
- 3002808270
- 3014314985
- 3003890648
- 3017026146
- 1250045
- 3024860669
- 3045077837
- 9710020
- 3006554788
- 3010198795
- 3034669683
- 3001644167
- 3013298431
- 3021133176
- 3015139713
- 3012309743
- 2027062
- 3009513193
- 3016758972
- 3006410968
- 1417592
- 1220477
- 3017417635
- 3011434305
- 3011715922
- 3035678069
- 3015505238
- 3027176414
- 2435946
- 3014610488
- 3030017177
- 1720747
- 3021680161
- 3015422337
- 9680874
- 3010951384
- 3024787345
- 9611274
- 3016450032
- 9611283
- 3013530901
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992995 | AROMATIC AND FLAVORED TONGUE DEPRESSOR | Aga Plastic Ind. Com. Ltda. | 1999-12-09 |
| K830705 | MINI LANCET-BLOOD LANCET | Pharmaquest Corp. | 1983-04-08 |
| K821177 | BITE STICK | Abco Dealers, Inc. | 1982-05-21 |
| K770120 | MOUTH WASH TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-01-28 |