510(k) K760494
- Device
- BASIN, ROUND WASH
- Applicant
- LANDMARK PLASTICS
- 510(k) number
- K760494
- Product code
- FNY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-11-12
- Date received
- 1976-08-23
- 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#
- 3018762668
- 3035708926
- 3018074706
- 9616088
- 9680411
- 3038613790
- 3005739529
- 3014579161
- 3014233824
- 9680026
- 8043816
- 3008850249
- 3013298431
- 3003887292
- 3003431869
- 8030607
- 3003244954
- 3013461194
- 3013497020
- 3014421917
- 3014610488
- 1526531
- 3011137372
- 3015173165
- 3010453313
- 3010339057
- 8040278
- 3003674698
- 3018071447
- 3012034017
- 3007378235
- 3012430011
- 3007681502
- 3035642068
- 3013429557
- 3005809810
- 3015505238
- 3007123908
- 1721676
- 3018326554
- 9611112
- 3043355002
- 1724474
- 3015166402
- 1928237
- 3024088964
- 3002974712
- 3020468145
- 3043153503
- 3018503755
- 3009109991
- 2183714
- 3004488394
- 3008494300
- 3015058854
- 3006617885
- 9613079
- 3009745997
- 3008902714
- 3005669815
- 3008797953
- 3010380518
- 3015895045
- 2320762
- 1421879
- 3023002332
- 1526854
- 1836161
- 3008572946
- 2530138
- 2530788
- 3013021474
- 3010000970
- 3017309443
- 3015337373
- 3004001706
- 3005720829
- 1422634
- 3006552462
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 |
| K760495 | BASIN, RECTANGULAR WASH | Landmark Plastics | 1976-11-12 |
| K760085 | BASIN, STERILE (#3200) | Concord Laboratories, Inc. | 1976-07-20 |
Legacy Summary#
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FDA Review#
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