FDA 510(k) Application Details - K000127

Device Classification Name	Weights, Eyelid, External   More FDA Info for this Device
510(K) Number	K000127
Device Name	Weights, Eyelid, External
Applicant	HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-I AMSTERDAM 1017 AP NL Other 510(k) Applications for this Company
Contact	DAGMAR MASER 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	01/18/2000
Decision Date	04/12/2000
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