Atlas FDA

DZIDRA GLASS FOR USE IN OPHTHALMOLOGY

FDA 510(k) clearance K864656 · decided 1987-02-25

Clearance details

K-number
K864656
Device name
DZIDRA GLASS FOR USE IN OPHTHALMOLOGY
Applicant
Glen Whitten, Dds
Decision
Substantially Equivalent
Date received
1986-11-28
Decision date
1987-02-25
Days to decision
89 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Lakeland, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.