510(k) K770120
- Device
- MOUTH WASH TRAY
- Applicant
- Pharmaseal Div., Baxter Healthcare Corp.
- 510(k) number
- K770120
- Product code
- FMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-28
- Date received
- 1977-01-21
- 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
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 3009503464
- 3034669683
- 3005440795
- 3004938767
- 3004039409
- 1250045
- 2024980
- 3006410968
- 3017231740
- 3019315696
- 3005951403
- 2080222
- 3015416207
- 1062671
- 3017910185
- 3010951382
- 8040278
- 8010099
- 3021282544
- 3035678069
- 1923569
- 3010374920
- 9611283
- 3010131137
- 3019387954
- 9613926
- 9710020
- 3004993527
- 3017026146
- 3016833936
- 3031582434
- 3010055973
- 3006542501
- 3012541976
- 2320762
- 8010159
- 1054241
- 3012309743
- 3009255580
- 3004014222
- 3008808049
- 9680874
- 3005273623
- 3002808270
- 9613910
- 3015422337
- 1216735
- 3007479164
- 1032347
- 3015505238
- 3005587147
- 8043685
- 1815540
- 1121142
- 3007187674
- 8010704
- 3003965134
- 3008808560
- 3010951384
- 3042896810
- 3003890648
- 9616872
- 9680271
- 1836161
- 1067135
- 3006411563
- 8022890
- 3010952189
- 3006973666
- 3035708926
- 3003644849
- 3012678246
- 3013632692
- 1043214
- 3014146451
- 8010155
- 3012104670
- 3012711490
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 |
| K842461 | TONGUE DEPRESSOR | The Torrent Corp. | 1984-11-30 |
| K830705 | MINI LANCET-BLOOD LANCET | Pharmaquest Corp. | 1983-04-08 |
| K821177 | BITE STICK | Abco Dealers, Inc. | 1982-05-21 |