510(k) K921191
- Device
- Gianturco-rosch Biliary Z Stent
- Applicant
- COOK, INC.
- 510(k) number
- K921191
- Product code
- FGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-15
- Date received
- 1992-02-27
- Regulation
- 876.5010
- Classification name
- Stents, Drains And Dilators For The Biliary Ducts
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- APRIL LAVENDER
- Address
- 925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402
FDA Registration Numbers
- 1450395
- 3014769442
- 1061124
- 3004129994
- 3002504068
- 3014328942
- 3035451914
- 3006131984
- 2183870
- 2183744
- 1222168
- 3012536737
- 3006260740
- 2032098
- 1644312
- 2134265
- 3001845648
- 3003910212
- 3011347300
- 3030447506
- 3011050570
- 3013557562
- 9616099
- 2024168
- 2246552
- 9616684
- 1225687
- 3031276312
- 1721676
- 1820334
- 2939561
- 3033589330
- 3006950086
- 1317547
- 3005099803
- 3013162291
- 3005089785
- 2126666
- 2024024
- 3002807314
- 1018233
- 1417485
- 9710284
- 1223925
- 3021009035
- 1828132
- 3030733800
- 1037905
- 1531050
- 3013337852
- 1625425
- 3008146331
- 3013152301
- 3014279513
- 3040505963
- 3010155661
- 9680809
- 1058584
- 3011146996
- 3008040402
- 3009526575
- 3014579161
- 3007695959
- 1928237
- 1000393132
- 3012480535
- 1724474
- 1319639
- 3004091615
- 3011458193
- 9681477
- 3009763019
- 3021632375
- 9614641
- 3008492676
- 3013460719
- 2030624
- 3009018440
- 3030446844
- 3027260597
- 3005941719
- 3013440400
- 3005580113
- 1000523114
- 3010273872
- 1123137
- 3009121749
- 1220477
- 2020394
- 3011642792
- 1643817
- 3003898360
- 8010047
- 2027111
- 3040096051
- 9681260
- 3004111573
- 2124215
- 3010220595
- 3004207966
- 1220592
- 3003790304
- 3011163668
- 1313046
- 3010173425
- 3013247477
- 3010419931
- 3006891655
- 3004837686
- 2015691
- 3016463905
- 2648045
- 1319211
- 2029386
- 3003902943
- 9680794
- 3007146453
- 3016678045
- 3004859241
- 3009906660
- 3010532612
- 3015225571
- 3006082230
- 3000247987
- 9710641
- 3014246639
- 9681442
- 1000121056
- 3011137372
- 3015309643
- 3014222368
- 3032916632
- 2011171
- 1721504
- 1219930
- 2528981
- 3013526170
- 3003775027
- 1528319
- 3005987240
- 1320894
- 1016427
- 3009051888
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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