510(k) K822260
- Device
- TRACHEAL DILATORS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822260
- Product code
- KCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-02
- Date received
- 1982-07-29
- Regulation
- 874.4420
- Classification name
- Dilator, Tracheal
- 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#
- 3023657851
- 9611112
- 3005440795
- 3004215117
- 2249529
- 2431166
- 1421879
- 1056350
- 8040278
- 3002090132
- 8010099
- 3010041511
- 3035678069
- 1923569
- 3010687973
- 3014615697
- 8010769
- 3008338766
- 8040263
- 9681540
- 9611283
- 9613926
- 3007597038
- 3002976036
- 8040172
- 3003244954
- 8043816
- 3015895045
- 8010422
- 3002675176
- 3013358456
- 9680304
- 9610773
- 3004001706
- 1836161
- 3010726901
- 9680515
- 3003644849
- 9680837
- 1820334
- 8040373
- 9616246
- 9611503
- 3013503739
- 3005813597
- 3003418325
- 9614093
- 1058584
- 3011137372
- 1417592
- 3002834291
- 8040233
- 8010298
- 3003334541
- 3007773213
- 1057946
- 2025182
- 9612074
- 3007648354
- 3021680161
- 9680519
- 9613079
- 3036795921
- 3008280196
- 3014334038
- 3013247477
- 3005809810
- 9710524
- 3005067367
- 3006554912
- 9612278
- 3003807268
- 8010485
- 3008770252
- 3001084743
- 9680518
- 3004608878
- 3003877407
- 9610905
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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