510(k) K922348

VALTRAC(R) INTRODUCER FORCEP by American Cyanamid Co. — Product Code HJE

K922348 is an FDA 510(k) premarket notification submitted by American Cyanamid Co. for the device "VALTRAC(R) INTRODUCER FORCEP". The FDA issued a decision of Substantially Equivalent on June 9, 1992. The device falls under product code HJE (Lamp, Fluorescein, Ac-Powered), a Class II device regulated under 21 CFR 878.4580. American Cyanamid Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1992
Date Received
May 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Fluorescein, Ac-Powered
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type