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#
- 3005024024
- 3032960221
- 9612051
- 3012391162
- 3010041511
- 9681385
- 3015781786
- 3003455467
- 3004950768
- 3004911384
- 9616874
- 1644312
- 3004513970
- 3010175283
- 3002468342
- 2246552
- 3015967359
- 3007305426
- 8030128
- 1921846
- 3038772401
- 3014314985
- 3026263452
- 3045857302
- 1225532
- 3005595283
- 2242656
- 3010610950
- 3003361112
- 3016096140
- 2244478
- 3010220595
- 1423537
- 3019543072
- 3006897996
- 3011089435
- 2028046
- 3011310668
- 8030654
- 3011434305
- 3025413691
- 3004617181
- 3010198795
- 3002722429
- 3011862887
- 3012598266
- 3016904853
- 3009542933
- 1221144
- 1422634
- 3019315696
- 2530138
- 3014257280
- 1314417
- 3024787345
- 3005273623
- 1223924
- 3045816902
- 3016970619
- 1058584
- 3016452400
- 2245304
- 3006379619
- 3017461134
- 1061124
- 3009756153
- 3013602181
- 3016170492
- 1043214
- 3031184338
- 3030067857
- 9613778
- 9616088
- 3017095924
- 2951379
- 3003965134
- 3004111573
- 2032098
- 3016758972
- 2029275
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