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#
- 3007082891
- 3005951296
- 2530138
- 3009486864
- 3010220595
- 3004519921
- 3007007790
- 1923569
- 3003887292
- 3010452421
- 1223924
- 3010175283
- 3025028726
- 3045058049
- 9680708
- 3009542933
- 3004111573
- 3021389253
- 1824619
- 3025413691
- 2242656
- 3013949389
- 3013530901
- 3034605486
- 9616872
- 1422598
- 3016170492
- 9616088
- 3016758972
- 9680222
- 3005663073
- 1058584
- 3011137372
- 3031184338
- 3030067857
- 3019543072
- 3032960221
- 3030394731
- 3004753358
- 9613778
- 3006973666
- 3009470597
- 3011689956
- 3026263452
- 3011862887
- 3009307523
- 3005024024
- 3045816907
- 8030128
- 1043214
- 3002722429
- 3014257280
- 2086043
- 3009526454
- 3014437893
- 3027605727
- 1319660
- 3004784537
- 1423395
- 3016904853
- 3019315696
- 3010041511
- 3010621964
- 1219313
- 2032098
- 3016659819
- 3035642068
- 3005112833
- 8030654
- 3016096140
- 2427500
- 3007305426
- 3004513970
- 2135152
- 9680455
- 3008879776
- 2246552
- 3013497020
- 1526534
- 9680271
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