510(k) K841760

WOODLYN CLASSIC INSTRUMENT STAND by Woodlyn, Inc. — Product Code HRJ

K841760 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN CLASSIC INSTRUMENT STAND". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code HRJ (Table, Instrument, Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
April 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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