510(k) K863989

THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) by Keeler Instruments, Inc. — Product Code HNC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1986
Date Received
October 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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