510(k) K822262
- Device
- ADENOTOMES
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822262
- Product code
- KBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-25
- Date received
- 1982-07-29
- Regulation
- 874.4420
- Classification name
- Adenotome
- 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#
- 3014334038
- 3006380247
- 9611112
- 1932180
- 3005809810
- 9611274
- 3011137372
- 3007137643
- 3006554912
- 1421879
- 1417592
- 1836161
- 8040278
- 3010726901
- 8010099
- 3010041511
- 3014615697
- 2916714
- 3003431869
- 3008770252
- 3035708926
- 9611283
- 9680518
- 8010155
- 3004608878
- 1421101
- 9616246
- 1313525
- 8030607
- 9680519
- 3003244954
- 1416666
- 3010699884
- 3003418325
- 3005528784
- 9610612
- 3009513193
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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