510(k) K884132
- Device
- Tecnol Bucks Traction W/heel Protector
- Applicant
- TECHNOL, INC.
- 510(k) number
- K884132
- Product code
- KQZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-11
- Date received
- 1988-09-30
- Regulation
- 888.5890
- Classification name
- Component, Traction, Non-Invasive
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEONA M HAMMEL
- Address
- 7201 Industrial Park Blvd. Fort Worth TX US 76180 76180
FDA Registration Numbers#
- 3020468145
- 1423537
- 2921578
- 3007299770
- 3013404959
- 3010987649
- 3015974593
- 3013700547
- 3016851379
- 3014982318
- 3019269298
- 3008110533
- 1026765
- 3014004349
- 1833053
- 3012883081
- 3010331645
- 3008048783
- 1054241
- 3040389283
- 1928237
- 8010100
- 3013957847
- 3005893246
- 1058152
- 3008008970
- 1218386
- 1220477
- 3027339877
- 3010273872
- 3007731000
- 3005180920
- 9616086
- 1055236
- 3013004243
- 3010675856
- 3003781173
- 1825034
- 3006210673
- 8030607
- 1824206
- 2530138
- 3014643275
- 3011230048
- 3015539532
- 8022890
- 3010536692
- 3021226419
- 1526534
- 3005273623
- 3021393544
- 1420032
- 1220246
- 3030681106
- 3016678045
- 1000649241
- 3004905643
- 3009936738
- 1836161
- 2320762
- 1043214
- 1320894
- 3012329552
- 1223962
- 3002579136
- 3007886583
- 3007319107
- 3010452421
- 3009610508
- 1054811
- 3017264244
- 3011295718
- 3012130008
- 3042898206
- 3020704423
- 3012818475
- 3010380518
- 3008770252
- 1643264
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KQZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | Tecnol New Jersey Wound Care, Inc. | 1988-07-27 |
| K871900 | OVER DRAPE LEG HOLDER | Avec Scientific Design Corp. | 1987-06-16 |
| K871296 | T.E.D.(TM) TRACTION DEVICE | The Kendal Co. | 1987-04-15 |
| K854270 | MURPHY ADJUSTABLE SPLINT | Comfortex, Inc. | 1985-12-09 |
| K831002 | TPG 1000 | Physical Diagnostics, Inc. | 1983-06-24 |
| K823660 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823163 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K821252 | HOFFMAN UNIVERSAL FOOT SUPPORT | Howmedica Corp. | 1982-06-22 |
| K802869 | BACKTRAC 90-90 TRACTION | Backtrac | 1980-12-11 |
| K781754 | SPLINT, HOAKE INFLATABLE AIR | Depuy, Inc. | 1978-11-08 |