510(k) K801853
- Device
- PARALLEL-A-PREP
- Applicant
- C.D. CHARLES, INC.
- 510(k) number
- K801853
- Product code
- EGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-13
- Date received
- 1980-08-04
- Regulation
- 872.4565
- Classification name
- Parallelometer
- Medical specialty
- Dental
- Review panel
- Dental
- 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#
- 3030488262
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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