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#
- 3014314985
- 1250045
- 3013557562
- 3009307523
- 3017041963
- 8040233
- 3043648115
- 3021282544
- 3016965929
- 3005587147
- 3005813597
- 3015745029
- 1216735
- 3035678069
- 3005460813
- 3003418325
- 1720747
- 9610612
- 3002714597
- 3012309743
- 9611283
- 3007187674
- 3014610488
- 3045853999
- 3007662999
- 3009308092
- 3008427684
- 3008280196
- 3021031769
- 3003890648
- 3014368824
- 1417592
- 3015505238
- 3016758972
- 3015337116
- 3007517215
- 3005440795
- 1055236
- 3012445994
- 9680934
- 3010872396
- 1423537
- 3030017177
- 3004993527
- 9611274
- 3011182134
- 3016509759
- 3011434305
- 1032347
- 2110420
- 1067135
- 3010155661
- 3013530901
- 8040278
- 2027062
- 9611959
- 3004938767
- 9615834
- 2183301
- 9680222
- 3044150131
- 3013632692
- 3014683120
- 9680874
- 9612278
- 3009503464
- 3009255580
- 8010155
- 3009513193
- 3007123908
- 3010951384
- 9613926
- 3005951403
- 8043554
- 3016763307
- 3005273623
- 3021133176
- 3010383831
- 3024860669
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 |