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#
- 3013674629
- 1926681
- 3034731665
- 1226544
- 3010880816
- 3007327621
- 3006113097
- 3014507028
- 1220477
- 3010952189
- 3004050854
- 1043534
- 1045254
- 3012358417
- 3043562110
- 3015337116
- 3011050570
- 3009403363
- 9611024
- 2028807
- 2135339
- 3014653790
- 2246552
- 3003364789
- 3032857006
- 3002858762
- 1018470
- 1213643
- 3003418325
- 3008719017
- 2031093
- 3016426830
- 3021082429
- 9612051
- 3010872396
- 3009134882
- 3017636737
- 3003775072
- 3002806953
- 3030733800
- 3010487482
- 3017475063
- 9612501
- 1645368
- 3009337401
- 3013187142
- 1424263
- 3005112833
- 3030653921
- 3004146122
- 3006789548
- 1450662
- 3002807315
- 3010951382
- 3015967359
- 1649518
- 2028632
- 3023598220
- 3002789796
- 3022140316
- 3023464160
- 3007225047
- 2183744
- 3011088743
- 3008729892
- 2032098
- 3040335671
- 3004111573
- 3003477135
- 3018094310
- 3008812251
- 3016678045
- 1223089
- 1037007
- 2029275
- 1928237
- 1061124
- 1219071
- 3015174190
- 3013517086
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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