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#
- 1417592
- 3007092328
- 8030107
- 3014683120
- 3004361903
- 3009107690
- 1526711
- 3004550973
- 1314417
- 2029275
- 3004111573
- 3010041511
- 3004548776
- 3006787036
- 1820334
- 3013058659
- 3004122598
- 3004365956
- 1643817
- 3007305485
- 1836161
- 3004605321
- 1319660
- 1450662
- 3015309643
- 1832653
- 3006128100
- 3041276591
- 3015183635
- 9616250
- 3009392898
- 9680721
- 3009642126
- 1000563940
- 3002808022
- 3030446844
- 1319211
- 3010806410
- 3040335671
- 1123137
- 3032912826
- 1313525
- 2210968
- 9681479
- 3006986257
- 3005483737
- 3031184338
- 3005987567
- 8030607
- 9680794
- 3005770916
- 3010202439
- 1018233
- 9610612
- 3016746538
- 3013160357
- 1424263
- 1119193
- 2020735
- 3010273872
- 3015972753
- 3033589330
- 3013764800
- 3015225571
- 1724474
- 9616088
- 3009039068
- 9681867
- 1000393132
- 3010896988
- 3042244574
- 3011642792
- 9614446
- 2124215
- 8041005
- 3003974574
- 8040278
- 1526611
- 3007007790
- 3011137372
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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