510(k) K843646

STEINWAY MICRO-KERATO-TREPHINE by Steinway Instrument Co., Inc. — Product Code HRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
September 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trephine, Manual, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type