510(k) K924784

BURTON PROJECTOR HEAD - MODEL 6000-H by R.H. Burton Co. — Product Code HOS

K924784 is an FDA 510(k) premarket notification submitted by R.H. Burton Co. for the device "BURTON PROJECTOR HEAD - MODEL 6000-H". The FDA issued a decision of Substantially Equivalent on April 5, 1993. The device falls under product code HOS (Projector, Ophthalmic), a Class I device regulated under 21 CFR 886.1680. R.H. Burton Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1993
Date Received
September 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Projector, Ophthalmic
Device Class
Class I
Regulation Number
886.1680
Review Panel
OP
Submission Type