FDA 510(k) Application Details - K964855

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K964855
Device Name	Sponge, Ophthalmic
Applicant	SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 ENGLEWOOD, CO 80112 US Other 510(k) Applications for this Company
Contact	SARAH MAXWELL LAKE Other 510(k) Applications for this Contact
Regulation Number	886.4790   More FDA Info for this Regulation Number
Classification Product Code	HOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/1996
Decision Date	03/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review