510(k) K830430

EYELID SPECULUM by Douglas C. Mckee & Co. — Product Code HNC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1983
Date Received
February 9, 1983
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