FDA 510(k) Application Details - K971245

Device Classification Name	Weights, Eyelid, External   More FDA Info for this Device
510(K) Number	K971245
Device Name	Weights, Eyelid, External
Applicant	IPAX, INC. 2109 WEST AMHERST AVE. ENGLEWOOD, CO 80110 US Other 510(k) Applications for this Company
Contact	PHIL PENNELL Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/1997
Decision Date	06/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review