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#
- 3005030934
- 3010598169
- 3017417635
- 3010175283
- 3010199022
- 3010131137
- 3045742729
- 1319639
- 3015219076
- 3010967704
- 3014819517
- 3038131023
- 8022899
- 3032172199
- 3007305426
- 3011248163
- 1043572
- 3008851420
- 3009155880
- 3012241417
- 3007360701
- 9611459
- 3014312726
- 3009470597
- 3008489813
- 3009600453
- 3006400320
- 3011862887
- 3023141635
- 3009503464
- 3003348807
- 3007307488
- 2320762
- 3004125670
- 3005327291
- 3030539818
- 3016970619
- 3004361903
- 3004513970
- 3012777736
- 1724809
- 3017936791
- 3004519921
- 1121142
- 3010147274
- 9680271
- 3011816517
- 2024980
- 3010610950
- 3004135030
- 3044150131
- 3013391391
- 3007187674
- 3045058049
- 3007028032
- 2028046
- 3019543072
- 3017461134
- 3009562494
- 1836546
- 3014368824
- 3010187826
- 3035786158
- 3007966889
- 3005460813
- 3005951296
- 2529394
- 3008076203
- 3012002722
- 3024891479
- 3010339057
- 3035382642
- 3005112833
- 3018228713
- 3015821396
- 3017231740
- 3003455467
- 3010515547
- 3003528228
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