510(k) K884483
- Device
- CRUCIOMETER
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K884483
- Product code
- JZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-18
- Date received
- 1988-10-25
- Regulation
- 874.4420
- Classification name
- Spoon, Ear
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT R MOORE
- Address
- 1897 National Ave. Hayward CA US 94545 94545
FDA Registration Numbers#
- 8030607
- 9613926
- 1417592
- 3008808049
- 9616246
- 3002858762
- 3016746538
- 2183416
- 3011137372
- 3035708926
- 3011066654
- 9611283
- 3014615697
- 3007006186
- 3009155880
- 1926681
- 8010155
- 3005695838
- 3010041511
- 3003418325
- 8040278
- 2084346
- 3005440795
- 3001408183
- 1836161
- 3011252788
- 3031564283
- 3003902419
- 3004001706
- 3003244954
- 3005974802
- 9613083
- 9611102
- 3005418651
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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