510(k) K870431
- Device
- GAUZE, ABSORBENT, IODOFORM IMPREGNATED
- Applicant
- STERIDYNE LABORATORIES, INC.
- 510(k) number
- K870431
- Product code
- GEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-26
- Date received
- 1987-02-03
- Regulation
- 510(k) Premarket Notification
- Classification name
- Gauze/sponge, Internal, 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
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER S REICHERTZ
- Address
- Washington Sq. 1050 Connecticut Ave. NW Washington DC US 20036 20036
FDA Registration Numbers#
- 1034876
- 1422634
- 3009109670
- 3011210302
- 3008562678
- 1836161
- 1649690
- 3038356900
- 3023994877
- 3003775072
- 3009171251
- 1423662
- 3017297225
- 3005694677
- 3017107376
- 3009504230
- 3010419931
- 3016904853
- 3004125670
- 3007187674
- 3009701308
- 3025431504
- 3007966889
- 1054241
- 9681630
- 3019843904
- 1036836
- 3039435289
- 3006784948
- 1018470
- 3006606901
- 1417411
- 3016851379
- 3009167225
- 3011987967
- 3005004019
- 3029971427
- 9615014
- 3004170064
- 3011238790
- 2183744
- 3010363503
- 3014004349
- 3045857302
- 1480288
- 3016116741
- 3012421607
- 3014146451
- 3032911850
- 3002787468
- 3002636527
- 3004681519
- 3007321028
- 3030926959
- 3034456223
- 3015276780
- 3004496953
- 9615662
- 3016678045
- 3015200795
- 2124143
- 1423507
- 3019944216
- 3007648359
- 3012481754
- 9616874
- 3009750086
- 2280705
- 3015142802
- 3003418325
- 3005920706
- 2083373
- 1646434
- 3014461810
- 3030229896
- 3017509841
- 9680091
- 1055236
- 3016450032
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