510(k) K822162
- Device
- MYRINGOTOMY KNIFE (VARIOUS TYPES)
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822162
- Product code
- JYP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-16
- Date received
- 1982-07-23
- Regulation
- 874.4420
- Classification name
- Knife, Myringotomy
- 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
- 3005809810
- 3023464160
- 3011137372
- 1416891
- 3005067367
- 1421879
- 3006098219
- 3004001706
- 1836161
- 8040278
- 3033526648
- 8010099
- 3010041511
- 3014615697
- 3013421458
- 2916714
- 3008770252
- 3008797953
- 3007773213
- 3008719017
- 9680837
- 9612075
- 1211998
- 3043355002
- 9680518
- 9613926
- 9680889
- 9611283
- 2529846
- 8044098
- 1926681
- 3013466775
- 3004608878
- 3012226300
- 9680519
- 8030607
- 3024021261
- 3003244954
- 3003418325
- 9610612
- 3015972835
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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