Atlas FDA

CF-1

FDA 510(k) clearance K063717 · decided 2007-01-23

Clearance details

K-number
K063717
Device name
CF-1
Applicant
Canon, Inc.
Decision
Substantially Equivalent
Date received
2006-12-14
Decision date
2007-01-23
Days to decision
40 days
Clearance type
Traditional
Product code
HKI
Device class
2
Regulation number
886.1120
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Lake Success, NY, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.