FDA 510(k) Application Details - K974286

Device Classification Name	Clamp, Circumcision   More FDA Info for this Device
510(K) Number	K974286
Device Name	Clamp, Circumcision
Applicant	TRINITY LABORATORIES, INC. 201 KILEY DR. SALISBURY, MD 21801 US Other 510(k) Applications for this Company
Contact	PARTHA BASUMALLIK Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/1997
Decision Date	12/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review