510(k) K832472
- Device
- ELEVATOR CUSHION
- Applicant
- INMED CORP.
- 510(k) number
- K832472
- Product code
- FWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-20
- Date received
- 1983-07-26
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8040233
- 2084346
- 3012986524
- 9680242
- 3006538822
- 2020550
- 8010099
- 3010380518
- 1828464
- 1825034
- 3010009693
- 3010170586
- 9681599
- 3009009512
- 3006697241
- 2028805
- 2518414
- 3010060157
- 3012595397
- 3037012186
- 3015177648
- 3006437555
- 3015960676
- 1043572
- 3008729549
- 1643264
- 3010595915
- 1017294
- 3005440795
- 3006400329
- 3001415205
- 3002579136
- 1223662
- 3015531959
- 3013700547
- 9616086
- 3023339277
- 3010033804
- 3007278668
- 1421879
- 2032098
- 1647149
- 1000655158
- 3012345110
- 1032347
- 3019269298
- 1054241
- 9680168
- 3004034546
- 3009888344
- 2030380
- 2183449
- 1526439
- 3010452421
- 1219602
- 1018470
- 9616088
- 3010123014
- 3007886583
- 3016851379
- 3011824442
- 3021839632
- 2031917
- 1320894
- 3010041511
- 3011137372
- 3010331645
- 3005726885
- 8043816
- 3014004349
- 3045857302
- 3017410889
- 8043817
- 3004491689
- 3008314176
- 3004361359
- 1053198
- 2248030
- 3001650535
- 2320762
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 |
| K905564 | PREP AND OPERATING STAND | Mcconnell Orthopedic | 1991-02-21 |
| K905565 | LATERAL BUTTRESS SUPPORT | 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 |
| K893969 | DECUBITUS CARE PAD | Gulftrade Exim, Inc. | 1989-07-14 |
| K890501 | SECOND ASSISTANT | 3M Company | 1989-02-10 |
| K885215 | LINCOLN MILLS HIP HOLDER | Lincoln Mills, Inc. | 1989-01-13 |
Legacy Summary#
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FDA Review#
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