510(k) K822165
- Device
- ENT CHISELS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822165
- Product code
- JYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-16
- Date received
- 1982-07-23
- Regulation
- 874.4420
- Classification name
- Chisel, Middle-ear
- 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
- 3001620590
- 9611112
- 3008936260
- 3005440795
- 3005809810
- 8010372
- 3011137372
- 1646747
- 3005067367
- 1421879
- 1056350
- 1417592
- 1836161
- 3002858762
- 1920664
- 8040278
- 3010041511
- 1923569
- 3010687973
- 2916714
- 3008770252
- 9680837
- 9611283
- 9613926
- 9617426
- 8010155
- 8044098
- 1926681
- 3007648354
- 3004608878
- 1421101
- 3012995405
- 1313525
- 8030607
- 3003418325
- 8040179
- 3005528784
- 9610612
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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