510(k) K822007
- Device
- BONE RONGEUNS ENT & RELATED ITEMS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822007
- Product code
- JZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-12
- Date received
- 1982-07-08
- Regulation
- 874.4420
- Classification name
- Rongeur, Mastoid
- 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#
- 8010099
- 8030607
- 3004608878
- 9613926
- 3036795921
- 8010168
- 9680515
- 3005809810
- 8010769
- 8010282
- 3011137372
- 3035708926
- 9611283
- 1926681
- 3005695838
- 2529846
- 3004215117
- 3012507533
- 3010041511
- 3003418325
- 8040278
- 1057946
- 9710524
- 3005440795
- 3016965929
- 3008902714
- 1836161
- 9610905
- 8040233
- 3005067367
- 3014334038
- 3013031133
- 9615857
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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