510(k) K842931

DRABKIN REAGENT by E K Ind., Inc. — Product Code KAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Speculum, Ent
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
Submission Type