510(k) K830675
- Device
- Oral Sponge
- Applicant
- UNISPLINT CORP.
- 510(k) number
- K830675
- Product code
- GEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-03-03
- Regulation
- 878.4800
- Classification name
- File, Surgical, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014334038
- 3002675176
- 2084346
- 3011371465
- 9616250
- 3005440795
- 3005809810
- 3019455
- 3004215117
- 3006410968
- 3011137372
- 1646747
- 9611274
- 2431166
- 3005067367
- 3007137643
- 1421879
- 9611102
- 1417592
- 3003032798
- 1834379
- 3002834291
- 8040278
- 3003807268
- 3010041511
- 3008902714
- 3014615697
- 3006487092
- 3003431869
- 3008770252
- 9613083
- 3008338766
- 3016050940
- 1057946
- 9614986
- 9612075
- 9611283
- 9680518
- 2529846
- 8044098
- 3007648354
- 8040884
- 9610905
- 9616246
- 8043496
- 1644408
- 3003244954
- 3010155661
- 8043816
- 3009340886
- 3003418325
- 3015895045
- 9680260
- 3000286616
- 1828464
- 3005061536
- 3036795921
- 3012447612
- 8010523
- 9610612
- 3009513193
- 1055890
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844145 | GENERAL SURGICAL FILES | Med-Tool, Inc. | 1984-11-20 |