510(k) K772381
- Device
- Ring Handle & Retractors
- Applicant
- EDWARD WECK, INC.
- 510(k) number
- K772381
- Product code
- KAL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-17
- Date received
- 1977-12-27
- Regulation
- 874.4420
- Classification name
- Retractor, 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#
- 3015451162
- 9614069
- 9610612
- 9680837
- 3014334038
- 8010704
- 1057421
- 9616250
- 9611262
- 3005809810
- 3001595398
- 3036795921
- 8044098
- 3009865268
- 8010374
- 3005067367
- 3010202439
- 1421101
- 3021680161
- 3004608878
- 8010422
- 3010829427
- 3002808270
- 9611278
- 8010733
- 3004001706
- 1032347
- 8010372
- 3006154292
- 5906
- 9611827
- 8010343
- 9710524
- 3011371465
- 1923569
- 3010455030
- 3013497507
- 3002675176
- 9611274
- 3010055973
- 9611112
- 3010726901
- 9610773
- 1313525
- 9613083
- 1720747
- 8010433
- 3008797953
- 8043467
- 8010851
- 8030607
- 2084346
- 2020550
- 3009513193
- 3013358456
- 8010155
- 2248180
- 3005440795
- 8040278
- 3003435550
- 1926681
- 3043355002
- 3008338766
- 3003418325
- 1836161
- 1057946
- 3006554912
- 1932214
- 3023657851
- 3003431869
- 3004215117
- 2916714
- 3005528784
- 3016965929
- 1417592
- 2434839
- 8010405
- 8010528
- 3008132398
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KAL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K870758 | SMALL MASTOID RETRACTOR | Treace Medical, Inc. | 1987-03-04 |
| K833604 | ADJUSTABLE FORK RETRACTOR | Microtek Medical, Inc. | 1984-01-03 |
| K772392 | ALLPORT MASTOID RETRACTORS | Edward Weck, Inc. | 1978-01-17 |
| K760851 | CONVERSE ALTAR RETRACTOR | V. Mueller O.V. Baxter Healthcare Corp. | 1977-03-10 |