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#
- 3008280196
- 3014334038
- 3013735158
- 3013528379
- 3005813597
- 3021666757
- 9680934
- 1923569
- 3010952189
- 3015416207
- 1058020
- 3003887292
- 3001644167
- 3003644849
- 3030017177
- 3004608878
- 3017231740
- 3005460813
- 8010159
- 9613910
- 3045058049
- 1000379039
- 2183301
- 3005440795
- 3015525259
- 8043769
- 3013530901
- 8030672
- 3017206126
- 9616872
- 3010951384
- 3010147274
- 9616088
- 3014683120
- 3016758972
- 9680222
- 3035708926
- 3031184338
- 3005621808
- 3042896810
- 3023917
- 3015337116
- 3045742729
- 3012314549
- 2916714
- 3006973666
- 8022890
- 3009307523
- 1043214
- 3014610488
- 3010420046
- 3006542501
- 1062671
- 3017910185
- 9615834
- 3027176414
- 3009255580
- 3004938767
- 3010951382
- 3021133176
- 9680518
- 3019315696
- 1219313
- 3016763307
- 3009513193
- 3004776555
- 8040233
- 3003890648
- 3005698350
- 3012678246
- 1032347
- 3004753334
- 3000682787
- 3006554788
- 9680271
- 3019387954
- 1054241
- 3044150131
- 9710020
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 |