510(k) K973703
- Device
- JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
- Applicant
- ALLEGIANCE HEALTHCARE CORP.
- 510(k) number
- K973703
- Product code
- GBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-04
- Date received
- 1997-09-26
- Regulation
- 878.4200
- Classification name
- Catheter, Irrigation
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH A MERTIS
- Address
- 1430 Waukegan Rd. Waukegan IL US 60085 60085
FDA Registration Numbers#
- 2084346
- 3008812560
- 2523676
- 2027062
- 1314417
- 3010621964
- 2020550
- 8010099
- 3033589330
- 9616250
- 3009392898
- 3034669683
- 3004472854
- 1836161
- 1423662
- 3017435705
- 1450662
- 3005483737
- 3013319212
- 3006542380
- 3023316
- 3008782989
- 8041005
- 3005770916
- 3042244574
- 1000112137
- 1820334
- 1017294
- 3004365956
- 1420054
- 2242352
- 2244478
- 2029386
- 3005440795
- 3006128100
- 3027977504
- 1123137
- 3001124136
- 3004468406
- 1721676
- 3006617533
- 3005067367
- 1313046
- 3011300255
- 1000393132
- 2437459
- 9615050
- 3002808022
- 9681867
- 3031783617
- 3006950086
- 3030447506
- 3012307300
- 3006673317
- 3018094310
- 3012536737
- 9710567
- 3032912826
- 3011642792
- 3013298431
- 2210968
- 1000523114
- 3017262697
- 1832653
- 1054241
- 3016746538
- 3010806410
- 3013058659
- 9681819
- 3009888344
- 3010155661
- 3017865161
- 1047843
- 3003793891
- 3010173425
- 3004548776
- 3017102971
- 3007738736
- 3003903031
- 3030078769
Source Documents#
Other 510(k) Records For Product Code GBX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131659 | MOERAE VEIN PREPARATION KIT | Moerae Matrix, Inc. | 2014-03-03 |
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | Maquet Cardiovascular, LLC | 2008-12-17 |
| K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | The Catheter Exchange, Inc. | 2005-10-21 |
| K043515 | GRAFTSAVER | Vescare, Inc. | 2005-03-31 |
| K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P | Misonix, Inc. | 2002-01-10 |
| K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | Dmc Medical, Ltd. | 2000-05-19 |
| K974233 | LYSONIX IRRIGATION SYSTEM | Lysonix, Inc. | 1998-02-03 |
| K972635 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Axiom Medical, Inc. | 1997-03-10 |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | Sil-Med Corp. | 1996-06-26 |
| K961147 | CLOSED FLUID COLLECTION SYSTEM | B.Braun Medical, Inc. | 1996-05-31 |
| K960955 | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING | Baxter Healthcare Corp | 1996-05-22 |
| K955339 | HYDROLOGY 5000 | Northgate Technologies, Inc. | 1996-03-13 |
| K955474 | NEO-PNEUMOCATH | Intra Special Catheters GmbH | 1996-02-13 |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1996-02-07 |
Legacy Summary#
summary
FDA Review#
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