510(k) K822184
- Device
- ENT METAL TONGUE DEPRESSORS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822184
- Product code
- KBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-16
- Date received
- 1982-07-23
- Regulation
- 874.4420
- Classification name
- Depressor, Metal Tongue, Surgical
- 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#
- 9611278
- 5906
- 1057946
- 3011625373
- 9611112
- 3010041511
- 9616250
- 3015451162
- 3036795921
- 9614062
- 1032347
- 3003807268
- 9680518
- 9613083
- 1421879
- 3004571672
- 3012226300
- 3006897996
- 3014615697
- 9610905
- 9710524
- 8010732
- 3031564283
- 3021680161
- 3003418325
- 2084346
- 3003431869
- 3015895045
- 8030607
- 3007648354
- 3011600579
- 1313525
- 3008902714
- 3009703496
- 3005327291
- 3007751820
- 3048101437
- 3005067367
- 9680837
- 3005809810
- 1932180
- 3017303999
- 3014620201
- 9611283
- 3021666757
- 3008936260
- 2529846
- 3012507533
- 3006554912
- 3004215117
- 9611274
- 3007137643
- 8040233
- 3032747418
- 8040278
- 3014683120
- 9610612
- 3006550126
- 3014334038
- 3002858762
- 3008808049
- 9680519
- 3002834291
- 3002976036
- 9681622
- 2431166
- 8040884
- 1926681
- 3022862651
- 3007773213
- 9611102
- 3007597038
- 3011137372
- 1066741
- 3005528784
- 3006487092
- 3003032798
- 3045811395
- 1836161
- 3004608878
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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