FDA 510(k) Application Details - K971832

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K971832
Device Name	Sponge, Ophthalmic
Applicant	M-PACT WORLDWIDE MANAGEMENT CORP. 1040 O.C.L. PKWY. INTECH BUSINESS PK. EUDORA, KS 66025 US Other 510(k) Applications for this Company
Contact	BARRY HALE 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	05/19/1997
Decision Date	07/31/1997
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