FDA 510(k) Application Details - K971465

Device Classification Name	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)   More FDA Info for this Device
510(K) Number	K971465
Device Name	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Applicant	NATIONAL HEALTHCARE MFG. CORP. 55 NORTHERN BLVD. GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	CAROLANN KOTULA Other 510(k) Applications for this Contact
Regulation Number	886.4750   More FDA Info for this Regulation Number
Classification Product Code	HOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1997
Decision Date	06/04/1997
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