510(k) K830263
- Device
- FLORET NASAL TAMPON
- Applicant
- RITMED, INC.
- 510(k) number
- K830263
- Product code
- GER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-01-25
- Regulation
- 510(k) Premarket Notification
- Classification name
- Gauze, External (with Drug/biologic/animal Source Material)
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- 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#
- 3010610457
- 1045254
- 1061124
- 3032857006
- 3002806953
- 2031093
- 3010872396
- 3011088743
- 3010880816
- 3006306415
- 1424263
- 2022502
- 3005112833
- 3003477135
- 1213643
- 3015337116
- 3016678045
- 3002806470
- 3012358417
- 3006524618
- 3034731665
- 3007788086
- 3040335671
- 1645368
- 1037007
- 3009337401
- 3015174190
- 3043562110
- 1219071
- 3003790304
- 2028632
- 3010487482
- 3004050854
- 3030733800
- 1220477
- 3006113097
- 3002789796
- 3002858762
- 1649518
- 3014507028
- 3008812251
- 1423662
- 3010951384
- 1450662
- 1928237
- 3011050570
- 3002807315
- 3006345872
- 3030653921
- 2028807
- 3010952189
- 3013517086
- 3007225047
- 3017636737
- 1219795
- 3010273872
- 1319660
- 3014345718
- 3007327621
- 1625425
- 3010951382
- 2183319
- 1048735
- 2246552
- 3003418325
- 2110420
- 3003364789
- 8010177
- 1043534
- 3008729892
- 3003915875
- 3016426830
- 3015967359
- 3004111573
- 3012448339
- 3017475063
- 1052728
- 3003775072
- 1526711
- 1223089
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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