Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K964080
Device Classification Name
Hearing Aid, Master
More FDA Info for this Device
510(K) Number
K964080
Device Name
Hearing Aid, Master
Applicant
LORI MEDICAL LABORATORIES, INC.
696 MENDELSSOHN AVE. NORTH
GOLDEN VALLEY, MN 55427-4306 US
Other 510(k) Applications for this Company
Contact
GARY R MAAS
Other 510(k) Applications for this Contact
Regulation Number
874.3330
More FDA Info for this Regulation Number
Classification Product Code
KHL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/1996
Decision Date
01/08/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact