510(k) K931037
- Device
- Whitmore Vacuum-lock Spinal Frame (vlsf-100)
- Applicant
- WHITMORE ENT., INC.
- 510(k) number
- K931037
- Product code
- FWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-07-30
- Date received
- 1993-03-01
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EARL HARMSEN
- Address
- Rt. 5 Box 369 San Antonio TX US 78221 78221
FDA Registration Numbers#
- 3004414785
- 3023339277
- 3010060157
- 2530138
- 3006154292
- 2921578
- 3012986524
- 3010170586
- 3010452421
- 3004133257
- 3004608878
- 1824206
- 3006535925
- 1825034
- 3009655869
- 3010009693
- 3004111573
- 3005440795
- 9616086
- 3014680784
- 3006437555
- 2011171
- 9614209
- 1223962
- 3007048220
- 9616088
- 1057425
- 3005438755
- 1058584
- 3011137372
- 8043816
- 3004361359
- 3014383485
- 1223662
- 2028805
- 2183449
- 3004034546
- 2916714
- 3030926959
- 3015177648
- 3045816907
- 1017294
- 1043214
- 1223419
- 3014004349
- 3001415205
- 3007663056
- 3007886583
- 1220246
- 1218386
- 3010041511
- 2032098
- 3003604053
- 3009009512
- 8040233
- 3027339877
- 3042872922
- 8021896
- 1032347
- 3005726885
- 9680215
- 3014273557
- 1018470
- 3007137643
- 1526534
- 1043572
- 1054241
- 3002579136
- 3007278668
- 3012595397
- 2032003
- 3010595915
- 3001650535
- 3015425095
- 3015960676
- 1055236
- 9710524
- 3012708860
- 8010168
- 3004361903
Source Documents#
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 |
| 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 |
| K884928 | FREE ARM(TM) | Faro Medical Technologies, Inc. | 1988-12-15 |