510(k) K760696

REMOTE CONTROL SYSTEM FOR MICROSCOPE by Alcon Laboratories — Product Code EPT

K760696 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "REMOTE CONTROL SYSTEM FOR MICROSCOPE". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code EPT (Microscope, Surgical), a Class I device regulated under 21 CFR 878.4700. Alcon Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
September 22, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type