510(k) K870761
- Device
- EAR LOOP
- Applicant
- TREACE MEDICAL, INC.
- 510(k) number
- K870761
- Product code
- JYQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-03
- Date received
- 1987-02-26
- Regulation
- 874.4420
- Classification name
- Loop, Wire
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS, JR
- Address
- Suite 400 22 N. Second St. Memphis TN US 38103 38103
FDA Registration Numbers#
- 3013358456
- 3007583964
- 8044098
- 3043355002
- 3005809810
- 9613079
- 3011137372
- 3009703496
- 1220246
- 9611112
- 3008338766
- 3001620590
- 8010935
- 9614062
- 3009513193
- 1058726
- 1417592
- 9615659
- 3035678069
- 3002858762
- 9680837
- 3021680161
- 3014004349
- 9611610
- 8040881
- 3006380247
- 9681622
- 3013557562
- 8043368
- 3013503739
- 3004215117
- 3010041511
- 8040278
- 9710524
- 1836161
- 1923569
- 9610905
- 2916714
- 9611102
- 3036795921
- 1421879
- 2031962
- 1932180
- 3008936260
- 1421101
- 9680718
- 3003418325
- 3009631939
- 3005440795
- 3031231776
- 9611262
- 8043752
- 1313525
- 3004001706
- 1056350
- 2249529
- 1935627
- 3008797953
- 8010099
- 8030607
- 3004608878
- 9613926
- 8010298
- 3010353847
- 3012995405
- 3003032798
- 3012185136
- 3006554912
- 3035708926
- 3005034064
- 1926681
- 2529846
- 1057946
- 2084346
- 9617426
- 3000264417
- 9610612
- 8040233
- 3005067367
- 3012226300
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JYQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890221 | MICROSURGICAL WIRE LOOP | Kinetic Medical Products | 1989-01-27 |
Legacy Summary#
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FDA Review#
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