510(k) K822011
- Device
- SHEA'S EAR SPECULUM HOLDER PORT MANNS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822011
- Product code
- JYK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-12
- Date received
- 1982-07-08
- Regulation
- 878.1800
- Classification name
- Holder, Ear Speculum
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- 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#
- 3001620590
- 3016904853
- 3008936260
- 3003322138
- 3005440795
- 3005809810
- 3011137372
- 3013530901
- 3010202439
- 1421879
- 1316463
- 2020550
- 3004001706
- 1928237
- 1836161
- 3002858762
- 8040278
- 3010726901
- 8010099
- 3010041511
- 3007840839
- 3008902714
- 3035708926
- 3014342096
- 3008770252
- 9613083
- 3008797953
- 3013784566
- 9680837
- 3043355002
- 9613926
- 3006703573
- 3006087789
- 3004608878
- 3003877407
- 3021680161
- 9680519
- 8030607
- 3004530184
- 3003418325
- 3012507533
- 3010707607
- 9610612
- 3008808049
- 9610621
- 3008280196
- 3033536312
- 3015972835
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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