510(k) K822253
- Device
- RASPS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822253
- Product code
- JYY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-25
- Date received
- 1982-07-29
- Regulation
- 874.4420
- Classification name
- Rasp, 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
- 3023657851
- 9611112
- 1932180
- 3005440795
- 3005809810
- 3007507973
- 8010372
- 3004215117
- 3011137372
- 1646747
- 9615857
- 3005067367
- 3007137643
- 1421879
- 1056350
- 3004001706
- 1417592
- 1928237
- 1836161
- 8040278
- 3010726901
- 3010041511
- 1923569
- 2916714
- 3008770252
- 9680837
- 9611283
- 9613926
- 9617426
- 3015143057
- 8044098
- 3004608878
- 1421101
- 1313525
- 8030607
- 2434839
- 1720747
- 3003418325
- 3005528784
- 9610612
- 9680718
- 3009513193
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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