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510(k) K964380

LC-250 INFRARED LIGHT COAGULATOR by Nk-Optik America — Product Code HQB

K964380 is an FDA 510(k) premarket notification submitted by Nk-Optik America for the device "LC-250 INFRARED LIGHT COAGULATOR". The FDA issued a decision of Substantially Equivalent on January 22, 1997. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
Date Received
November 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

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FDA data resources