510(k) K020318
- Device
- SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
- Applicant
- SCIVOLUTIONS, INC
- 510(k) number
- K020318
- Product code
- MXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-03
- Date received
- 2002-01-30
- Regulation
- 510(k) Premarket Notification
- Classification name
- Tape And Bandage, Adhesive (with Disinfectant)
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ART WARD
- Address
- 962 Allegro Ln. Appollo Beach FL US 33572 33572
FDA Registration Numbers#
- 3005533873
- 3004727227
- 3008132238
- 2431014
- 3008132398
- 3009109670
- 3002636527
- 1048735
- 3008396914
- 3012979524
- 1047843
- 3006784948
- 3013298431
- 1000317571
- 3005315793
- 3042953785
- 3005761322
- 3003418325
- 3007735241
- 3013671177
- 3016807311
- 3044026004
- 1038758
- 3031180770
- 2529394
- 9680143
- 3018153007
- 3013133723
- 3006498370
- 3011191255
- 3010452421
- 3020745223
- 3015309358
- 3013521734
- 9680731
- 3013478891
- 8044178
- 1066368
- 1225598
- 3009348823
- 3008750913
- 3043618351
- 3007648359
- 3012111117
- 1643817
- 3006633581
- 3019843904
- 8030673
- 3010770024
- 3003185698
- 1225532
- 3006802076
- 3015142802
- 3007048057
- 3010131715
- 3026399481
- 1649690
- 3036978602
- 3007966889
- 2031987
- 3015821396
- 2218158
- 3010610950
- 3010155648
- 3005113244
- 3007329020
- 3010419931
- 3007594734
- 3024856793
- 3010315629
- 3007502289
- 3007605720
- 1720929
- 3005941719
- 3027977504
- 1417592
- 3011987967
- 3016904853
- 1036836
Source Documents#
Legacy Summary#
summary
FDA Review#
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