510(k) K915299

COGAN CORP KITS OF DENTAL HAND INSTRUMENTS by Cogan Corp. — Product Code EGG

K915299 is an FDA 510(k) premarket notification submitted by Cogan Corp. for the device "COGAN CORP KITS OF DENTAL HAND INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on January 31, 1992. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1992
Date Received
November 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Precision, All
Device Class
Class I
Regulation Number
872.3165
Review Panel
DE
Submission Type