510(k) K883575

MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE by Site Microsurgical Systems, Inc. — Product Code HMG

K883575 is an FDA 510(k) premarket notification submitted by Site Microsurgical Systems, Inc. for the device "MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE". The FDA issued a decision of Substantially Equivalent on September 12, 1988. The device falls under product code HMG (Stand, Instrument, Ophthalmic, Non-Powered), a Class I device regulated under 21 CFR 886.1860. Site Microsurgical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1988
Date Received
August 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Instrument, Ophthalmic, Non-Powered
Device Class
Class I
Regulation Number
886.1860
Review Panel
OP
Submission Type