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#
- 3002976036
- 2084346
- 8043752
- 3003244954
- 3022862651
- 3015451162
- 3006487092
- 3014620201
- 8040263
- 3014615697
- 3027187888
- 9611278
- 9614062
- 3003431869
- 3015895045
- 3002858762
- 3002834291
- 3008808049
- 1923569
- 1057946
- 3007137643
- 3012995405
- 3011600579
- 3017303999
- 3008770252
- 3006554912
- 9610612
- 3004571672
- 3008936260
- 3007648354
- 9611503
- 3003882387
- 9613926
- 1932180
- 3003877407
- 3009513193
- 3031564283
- 9680837
- 8040278
- 9611274
- 9610621
- 9710524
- 1926681
- 3016763307
- 2431166
- 3004608878
- 3009307523
- 3032747418
- 3035678069
- 3013358456
- 3003807268
- 3014683120
- 3010041511
- 3013530901
- 3007597038
- 3010399422
- 3021666757
- 3005587147
- 3014334038
- 1032347
- 9613079
- 3012226300
- 8010732
- 9612086
- 3036795921
- 1313525
- 3005440795
- 3011669217
- 1836161
- 3006550126
- 9616250
- 3010055973
- 3005528784
- 9613083
- 3013846070
- 1417592
- 3021680161
- 8010155
- 3004001706
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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