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#
- 3005440795
- 3012207247
- 3011715922
- 3012314549
- 3013557562
- 3021133176
- 3010872396
- 3009255580
- 3004039409
- 3010374920
- 3017910185
- 3004938767
- 3015416207
- 8043685
- 3008808560
- 3011529314
- 3010951382
- 3045742729
- 9710524
- 3045077837
- 3015422337
- 1032347
- 3013784566
- 3021031769
- 3014620201
- 3009503464
- 3005460813
- 3010952189
- 3005083505
- 3024088964
- 8040233
- 9611503
- 3005739529
- 3006210673
- 3016763307
- 3019315696
- 3021031939
- 3004776555
- 3017026146
- 1220477
- 8030607
- 3045526618
- 9615834
- 3006789548
- 3015140199
- 3015525259
- 3006554788
- 3011182134
- 3012309743
- 9612278
- 3004993527
- 8043554
- 3045058049
- 9616872
- 3007187674
- 3032597249
- 3015745029
- 3003902419
- 3010339057
- 3017231740
- 3008386507
- 3013298431
- 3008808082
- 1043214
- 1423537
- 3008808049
- 3003890648
- 1250045
- 1720747
- 9611262
- 3008427684
- 3016758972
- 8043512
- 2110420
- 3014314985
- 3003644849
- 3005621808
- 1219313
- 3017041963
- 3017206126
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 |