510(k) K900476

WOODLYN SLIT LAMP MODEL HR-1 by Woodlyn, Inc. — Product Code HJO

K900476 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN SLIT LAMP MODEL HR-1". The FDA issued a decision of Substantially Equivalent on February 21, 1990. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1990
Date Received
February 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type