510(k) K760697

EVANS ARM AND HAND REST by Alcon Laboratories — Product Code HRK

K760697 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "EVANS ARM AND HAND REST". The FDA issued a decision of Substantially Equivalent on November 2, 1976. The device falls under product code HRK (Table, Instrument, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Alcon Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1976
Date Received
September 22, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Instrument, Manual, Ophthalmic
Device Class
Class I
Regulation Number
886.4855
Review Panel
OP
Submission Type