510(k) K822186
- Device
- MACKENZIE'S TONSILLECTOME
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822186
- Product code
- KCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-25
- Date received
- 1982-07-23
- Regulation
- 874.4420
- Classification name
- Tonsillectome
- 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#
- 8030607
- 9613926
- 1417592
- 8010298
- 3007597038
- 3011137372
- 9611274
- 9611283
- 1421101
- 3003807268
- 1926681
- 9616419
- 3010041511
- 8040278
- 9611112
- 1836161
- 9610612
- 3005528784
- 2916714
- 9611102
- 3010594904
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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