510(k) K893969
- Device
- Decubitus Care Pad
- Applicant
- GULFTRADE EXIM, INC.
- 510(k) number
- K893969
- Product code
- FWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-07-14
- Date received
- 1989-06-02
- Regulation
- 878.4950
- Classification name
- Operating Room Accessories Table Tray
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEFFLER
- Address
- 1298 Som Center Rd. Suite 102 Mayfield Heights OH US 44124 44124
FDA Registration Numbers#
- 3010170586
- 3037012186
- 1053198
- 1423537
- 3031582440
- 3012777736
- 3006538822
- 2183449
- 3015425095
- 9610612
- 2921578
- 3008729549
- 1526350
- 3006535925
- 2028805
- 3007289408
- 3015974593
- 3001415205
- 1423395
- 3013700547
- 1223419
- 2182536
- 3016851379
- 3042872922
- 3019269298
- 3009009512
- 3015177648
- 3014004349
- 3010033804
- 3010202439
- 3011547624
- 2518414
- 9616088
- 2011171
- 3010331645
- 3010123014
- 3001650535
- 3004608878
- 1054241
- 3017410889
- 3012595397
- 1018470
- 9680168
- 1032347
- 9680242
- 3006154292
- 9710018
- 1057425
- 1526439
- 9710524
- 1218386
- 9680215
- 3027339877
- 3005061536
- 3014623126
- 3007143236
- 9616086
- 1055236
- 3023339277
- 3006697241
- 3004111573
- 3006654680
- 9681599
- 1825034
- 2031917
- 1000655158
- 2126670
- 2084346
- 1824206
- 1643817
- 3014680784
- 1223662
- 2530138
- 2020550
- 3011230048
- 3008489813
- 2030380
- 3004034546
- 3021226419
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FWZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960019 | RETRACTOR ARM CLAMP | Biopsys Medical, Inc. | 1996-02-09 |
| K945415 | 'LIL MAC ACCESSORY CLAMP(TM) | D.L. Nelson and Assoc., Inc. | 1994-11-22 |
| K944779 | CARBON LIGHTS HAND SURGERY TABLE | Allen Medical Systems, Inc. | 1994-10-14 |
| K935381 | KAPS POSITIONING ARM | Andronic Devices, Ltd. | 1994-04-15 |
| K931037 | WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) | Whitmore Ent., Inc. | 1993-07-30 |
| K926225 | SPONGE COUNTER | American Medical Manufacturer, Inc. | 1993-03-05 |
| K925035 | MIDKIFF GEOSTATIC CLAMP | D.L. Nelson and Assoc., Inc. | 1993-02-18 |
| K905565 | LATERAL BUTTRESS SUPPORT | Mcconnell Orthopedic | 1991-02-21 |
| K905564 | PREP AND OPERATING STAND | Mcconnell Orthopedic | 1991-02-21 |
| K910031 | PARK CITY SHOULDER POSITIONER | Orthopedic Systems, Inc. | 1991-01-24 |
| K904826 | TKO TELESCOPING LITHOTOMY STIRRUP | D.L. Nelson and Assoc., Inc. | 1990-10-31 |
| K897028 | LINCOLN MILLS FOOT AND LEG HOLDER | Lincoln Mills, Inc. | 1990-01-12 |
| K890501 | SECOND ASSISTANT | 3M Company | 1989-02-10 |
| K885215 | LINCOLN MILLS HIP HOLDER | Lincoln Mills, Inc. | 1989-01-13 |
| K884928 | FREE ARM(TM) | Faro Medical Technologies, Inc. | 1988-12-15 |