510(k) K910857
- Device
- ALLDRESS MULTI LAYERED WOUND DRESSING
- Applicant
- SCOTT HEALTH CARE
- 510(k) number
- K910857
- Product code
- GER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-04-12
- Date received
- 1991-02-28
- 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#
- Contact
- RICHARD A HAMER
- Address
- Scott Plz. Iii Philadelphia PA US 19113 19113
FDA Registration Numbers#
- 3011767135
- 3008294339
- 3007407626
- 1219071
- 3006379619
- 3004911384
- 3013735158
- 3019804885
- 3014925393
- 1121142
- 2320762
- 3023191945
- 3044819802
- 9616518
- 3013421458
- 3004547763
- 3031982537
- 3006425876
- 3023339277
- 3003915875
- 1250045
- 3019458442
- 2183416
- 3011862887
- 3017095924
- 3017248120
- 9612354
- 3015416207
- 2183301
- 3009503464
- 3003674698
- 3005034064
- 9616088
- 3030067857
- 3009167225
- 3013525704
- 9616874
- 1000115322
- 3009756153
- 3016826509
- 3007366790
- 3006847952
- 3030017177
- 1313700
- 3011647251
- 3013919644
- 1649518
- 3045816907
- 3008386507
- 3010583458
- 3016734231
- 3016746332
- 3004488394
- 3023917
- 9680222
- 3010967704
- 3010621964
- 3014368824
- 3011193403
- 3044995512
- 3004176951
- 3005951403
- 3008392711
- 3031288561
- 3007007790
- 3016452400
- 3010401517
- 3008191276
- 1421873
- 1030451
- 3015821396
- 3008950965
- 3006210673
- 8021899
- 3015437221
- 2431166
- 3035382642
- 3013557562
- 3008808560
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