510(k) K833626
- Device
- FLORET FOAM PREP SPONGE
- Applicant
- RITMED, INC.
- 510(k) number
- K833626
- Product code
- GER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-17
- Date received
- 1983-10-14
- 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#
- 3032960221
- 3030067857
- 1422634
- 3012391162
- 2027062
- 3004617181
- 1314417
- 3010621964
- 3006538822
- 3012598266
- 3034669683
- 3010380518
- 1836161
- 3004513970
- 3038162648
- 2024311
- 3003455467
- 3009486864
- 3025028726
- 3005663073
- 2242656
- 3009134882
- 3016096140
- 3011862887
- 3019315696
- 3013949389
- 3008851420
- 2135152
- 2032112
- 2086043
- 3005951296
- 3021389253
- 2083545
- 1043572
- 2427500
- 3004998166
- 3011310668
- 3038718579
- 3009114792
- 3010220595
- 1923569
- 2244478
- 3003636207
- 3031982537
- 3027977504
- 3018269545
- 3012050423
- 3013497020
- 3016452400
- 3001124136
- 3016904853
- 1720929
- 3014421917
- 3030394731
- 3010198795
- 3015781786
- 3002858762
- 3011089435
- 1048735
- 3035642068
- 3009470597
- 3006847952
- 3003361112
- 3002532929
- 3007299770
- 3011524630
- 2032098
- 3019543072
- 3004950768
- 3004753358
- 3013298431
- 3014437893
- 1054241
- 3002468342
- 1047843
- 3027605727
- 3039388855
- 3000256895
- 1423395
- 3010452421
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases