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OPD-SCAN, MODELS ARK-10000 AND ARK-9000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003299
510(k) Type
Traditional
Applicant
NIDEK CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/9/2001
Days to Decision
140 days
Submission Type
Summary

OPD-SCAN, MODELS ARK-10000 AND ARK-9000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003299
510(k) Type
Traditional
Applicant
NIDEK CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/9/2001
Days to Decision
140 days
Submission Type
Summary