510(k) K760085
- Device
- BASIN, STERILE (#3200)
- Applicant
- CONCORD LABORATORIES, INC.
- 510(k) number
- K760085
- Product code
- FNY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-07-20
- Date received
- 1976-06-21
- Regulation
- 880.6730
- Classification name
- Basin, Emesis
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 3045816907
- 2435946
- 3015058854
- 1421879
- 3006636962
- 3001644167
- 3005809810
- 9616088
- 3017309443
- 2530788
- 3031184338
- 3043355002
- 3005067367
- 3009745997
- 1062671
- 3005012805
- 3008936260
- 3013461194
- 3018762668
- 3045816902
- 3038191347
- 3009109991
- 3009408502
- 3035642068
- 3018326554
- 3016746538
- 3013557562
- 1034116
- 2320762
- 3014615697
- 3017674087
- 3023002332
- 3043126908
- 3018071447
- 1054241
- 3007407626
- 1018233
- 9611590
- 3005720829
- 3008467060
- 3008489813
- 3010041511
- 3010339057
- 3015173212
- 3015173165
- 3012354669
- 1423537
- 3004122598
- 3005595283
- 3003701178
- 9613079
- 3015276780
- 1057946
- 3005515211
- 1526854
- 3010453313
- 3004513970
- 3007695020
- 8030607
- 1055236
- 9611283
- 3015499242
- 1928237
- 1526531
- 1721676
- 3006538822
- 3001124136
- 1417592
- 3013021474
- 3006455037
- 3011137372
- 3013558039
- 3018503755
- 3004111573
- 3009513193
- 3005440795
- 1043214
- 9616246
- 3010420046
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FNY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | American Hospital Supply Corp. | 1984-04-23 |
| K802538 | BASIN PACK | Texas Medical Products, Inc. | 1980-10-31 |
| K800440 | STERILE SPONGE BOWLS | Premium Plastics, Inc. | 1980-04-29 |
| K792625 | STERILIZATION PROCESS/PLACENTA BASIN | Procter & Gamble Mfg. Co. | 1980-01-16 |
| K771733 | 8 EMESIS BASIN | Bemis Health Care | 1977-09-28 |
| K760492 | BASIN, LARGE OR SMALL | Landmark Plastics | 1976-11-12 |
| K760494 | BASIN, ROUND WASH | Landmark Plastics | 1976-11-12 |
| K760495 | BASIN, RECTANGULAR WASH | Landmark Plastics | 1976-11-12 |
Legacy Summary#
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FDA Review#
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