FDA 510(k) Application Details - K971299

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K971299
Device Name	Hearing Aid, Air Conduction
Applicant	SCIENTIFIC PLASTICS, INC. 243 WEST 30TH ST. NEW YORK, NY 10001 US Other 510(k) Applications for this Company
Contact	JEFFREY STEGMAN Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	ESD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1997
Decision Date	06/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review