510(k) K896134
- Device
- ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.
- Applicant
- GOOSEN ENTERPRISES, INC.
- 510(k) number
- K896134
- Product code
- GCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-30
- Date received
- 1989-10-24
- Regulation
- 880.6740
- Classification name
- Apparatus, Suction, Operating-room, Wall Vacuum Powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARL C GOOSEN
- Address
- P.O. Box 10 Goldenrod FL US 32733 32733
FDA Registration Numbers#
- 3008264111
- 3010170586
- 1423537
- 3017540705
- 3017635043
- 2029275
- 3003674698
- 2032476
- 9610612
- 2244478
- 1216677
- 3013440654
- 3030979378
- 3004986960
- 1057421
- 3006897996
- 1423395
- 3005587132
- 3007305485
- 8010177
- 2649614
- 3010396502
- 3013735622
- 3010834934
- 3016601021
- 3006395447
- 2648623
- 3010202439
- 2032112
- 1047843
- 9616088
- 2936485
- 2011171
- 2433012
- 3010966951
- 8030673
- 3004476158
- 1048735
- 3002732769
- 1319639
- 3007203968
- 1054241
- 9610632
- 3014420084
- 1928237
- 1424785
- 3029917416
- 3003481016
- 3004137296
- 3011198121
- 1018470
- 3020796687
- 3043747738
- 8010273
- 9611500
- 1032347
- 3006606984
- 3012445205
- 1526439
- 3027645317
- 1818910
- 9611827
- 2029015
- 9614434
- 1921846
- 3016080683
- 1422634
- 3021244152
- 1055236
- 3004111573
- 3008797953
- 3006446479
- 3011182134
- 3022568093
- 3010221586
- 3012075008
- 1034117
- 1643817
- 3038637162
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042454 | STRYKER CASSETTE PUMP | Stryker Endoscopy | 2004-12-09 |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | Circon Corp. | 1999-08-03 |
| K972074 | SUCTION INSTRUMENTATION | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| K971022 | CHASE SUCKER | Chase Medical, Inc. | 1997-04-17 |
| K964127 | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | Allegiance Healthcare Corp. | 1996-12-31 |
| K964519 | CURITY THORACENTESIS TRAY | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 |
| K963648 | STRYKER SUCTION REGULATOR | Stryker Endoscopy | 1996-11-26 |
| K962920 | RENTON SUCTION DEVICE U.S. PATENT*4,767,404 | R&S Surgical, LLC | 1996-10-21 |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Medcare Medical Group, Inc. | 1996-07-19 |
| K960223 | CPR YANKAUER | Custom Pack Reliability | 1996-03-28 |
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Medcare Custom Packaging, Inc. | 1996-01-19 |
| K954726 | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) | Stryker Endoscopy | 1995-11-29 |
| K952219 | SUCTION TIP CLEANER CUP | Moore/Gobel | 1995-11-15 |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-13 |
| K950464 | SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES | Sscor | 1995-04-25 |
Legacy Summary#
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FDA Review#
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