510(k) K822183
- Device
- MOUTH GAGS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822183
- Product code
- KBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-16
- Date received
- 1982-07-23
- Regulation
- 874.4420
- Classification name
- Gag, Mouth
- 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#
- 3013552516
- 3010594904
- 8043396
- 3034246182
- 3005813597
- 9614069
- 9610612
- 3014656749
- 9680837
- 3013440654
- 3014334038
- 3015512299
- 3010442693
- 8010704
- 3001297506
- 8043496
- 8040884
- 2431166
- 3005809810
- 8010159
- 3036795921
- 3009255580
- 1055890
- 9680518
- 3005067367
- 3010202439
- 3009968482
- 1421101
- 3007064566
- 3015895045
- 3043648115
- 9681540
- 3004608878
- 3007751820
- 3004992978
- 3010829427
- 3002808270
- 3004472854
- 3009703496
- 1422507
- 3004001706
- 2246990
- 3019404837
- 3002769835
- 1032347
- 9611102
- 5906
- 9710524
- 3013188547
- 1937100
- 3011371465
- 3015191173
- 1923569
- 8043235
- 3013497507
- 9611274
- 9611112
- 9611503
- 1313525
- 3010402691
- 9613083
- 3007597038
- 3035708926
- 3004598675
- 3010864832
- 2424366
- 3001146947
- 9680002
- 8030607
- 1416605
- 8040881
- 3005621335
- 3003407244
- 3002761766
- 3013152643
- 3011625373
- 3009513193
- 2020550
- 3015351976
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KBN #
Legacy Summary#
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FDA Review#
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