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#
- 3005440795
- 3022928161
- 3015225571
- 3002808022
- 3007279848
- 2029386
- 1017294
- 3013557562
- 9614446
- 3007305485
- 1061124
- 1057421
- 8030107
- 3014936217
- 1820334
- 3009888344
- 3004122598
- 3004483571
- 3012494290
- 3014457631
- 3041276591
- 3010208880
- 2020550
- 1319639
- 3032912826
- 2437459
- 3004550973
- 9680741
- 3005770916
- 2242352
- 9681479
- 8041005
- 2124215
- 3008810357
- 3027977504
- 2245304
- 2210968
- 1220246
- 9616088
- 3018114242
- 3012421607
- 3010452421
- 8030607
- 3016746538
- 8030673
- 1061771
- 3003800209
- 1526611
- 3006986257
- 1018233
- 3004365956
- 1058584
- 1480288
- 1319660
- 3034731361
- 3010202439
- 3045058049
- 3015967359
- 3015231789
- 1420054
- 1222168
- 3023316
- 1000523114
- 3011137372
- 3013909820
- 3030078769
- 3017262697
- 3013298431
- 1043214
- 9681867
- 1423537
- 3006950086
- 2518902
- 3010896988
- 3004361903
- 1832653
- 3033589330
- 3003903031
- 3010273872
- 3010400865
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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