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#
- 3010610457
- 3010131137
- 3010656982
- 3011089435
- 9616088
- 3004605321
- 1061124
- 3007305426
- 3045058049
- 3010610950
- 3031184338
- 3026263452
- 1526534
- 2024311
- 9612354
- 3016904853
- 3008663306
- 3010380518
- 3025413691
- 1720929
- 3009114792
- 3021247124
- 3030394731
- 3005112833
- 3011137372
- 9611959
- 3010452421
- 3010621964
- 3012050423
- 3015058854
- 3003887292
- 3015781786
- 3004998166
- 2648727
- 3001124136
- 3038718579
- 3011529314
- 3005024024
- 3014314985
- 2242656
- 1422598
- 3012391162
- 3016970619
- 3010198795
- 3013602181
- 3039388855
- 3013298431
- 3034669683
- 1219071
- 3027977504
- 3016659819
- 2027062
- 3016758972
- 3013502418
- 3004617181
- 3038772401
- 1018120
- 3034629649
- 1220477
- 1417592
- 9680455
- 3011434305
- 2245304
- 3007007790
- 3014257280
- 3002858762
- 2427500
- 1223924
- 2435946
- 3014926389
- 3003636207
- 1221144
- 3017095924
- 1060680
- 9680091
- 3005663073
- 3004950768
- 3030067857
- 3012660022
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