510(k) K822372
- Device
- OFFICE ECONO-FORCEPS
- Applicant
- TREACE MEDICAL, INC.
- 510(k) number
- K822372
- Product code
- KAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-09
- Date received
- 1982-08-06
- Regulation
- 874.4420
- Classification name
- Forceps, Ent
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- 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#
- 3010055973
- 3008711893
- 3016248634
- 9616088
- 1061124
- 3039414397
- 3008808049
- 8043507
- 3010155661
- 1032347
- 9616250
- 3025303963
- 3003882387
- 3013358456
- 3013247477
- 8010370
- 3043355002
- 3005809810
- 8010769
- 8010257
- 1920664
- 2020550
- 3015451162
- 3033536312
- 9613079
- 3011137372
- 3014201171
- 3010455030
- 3010202439
- 3012422952
- 3004168759
- 1526854
- 3006098219
- 8010269
- 1057421
- 3003431869
- 3003038445
- 9611112
- 3002807115
- 3008280196
- 3008338766
- 3002808270
- 3008902714
- 3031564283
- 3001620590
- 3015895045
- 1057358
- 1055890
- 3010726901
- 9610773
- 9614062
- 3009513193
- 2248180
- 8010422
- 9611814
- 3003435550
- 3006410968
- 1417592
- 3023657851
- 3011310592
- 3035678069
- 3002858762
- 3006517555
- 8010523
- 1720747
- 9680837
- 3008812251
- 3021680161
- 8010254
- 9612277
- 3004571672
- 9710014
- 8010890
- 9680519
- 3002090132
- 3030644259
- 3007773213
- 9611274
- 3006380247
- 8010617
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853708 | LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE | Downs Surgical , Ltd. | 1986-02-14 |
| K851775 | 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS | Artiberia | 1985-06-11 |
| K851794 | 41-180 TO 41-246 VARIOUS NASAL FORCEPS | Artiberia | 1985-06-11 |
| K851795 | 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS | Artiberia | 1985-06-11 |
| K833608 | GOLD ALLIGATOR FORCEPS | Microtek Medical, Inc. | 1984-01-11 |
| K833605 | CUPPED FORCEPS | Microtek Medical, Inc. | 1984-01-03 |
| K833607 | MCGEE FORCEPS | Microtek Medical, Inc. | 1984-01-03 |
| K822369 | MICRO & MINI-MICRO ALLIGATOR FORCEPS | Treace Medical, Inc. | 1982-09-09 |
| K812895 | YARMO NASAL CARTILAGE SOFTENER | American V. Mueller | 1981-11-02 |
| K772377 | HILDYARD POST NASAL FORCEP | Edward Weck, Inc. | 1978-01-17 |
| K772396 | ALLIGATOR CUP FORCEPS | Edward Weck, Inc. | 1978-01-17 |
| K772397 | COTTLE COLUMELLA FORCEP | Edward Weck, Inc. | 1978-01-17 |
| K772398 | COTTLE LOWER LATERAL FORCEPS | Edward Weck, Inc. | 1978-01-17 |
Legacy Summary#
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FDA Review#
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