FDA 510(k) Application Details - K982276

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K982276
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	MICROPTIX INT'L, LLC. 310 MAIN ST., SUITE LL-D EAST HAVEN, CT 06512 US Other 510(k) Applications for this Company
Contact	GEORGE N HALLACK Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/1998
Decision Date	02/18/1999
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