LORI/LORI, LORI-S (LORI STOCK AID)

Hearing Aid, Air Conduction

LORI MEDICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by Lori Medical Laboratories, Inc. with the FDA for Lori/lori, Lori-s (lori Stock Aid).

Pre-market Notification Details

Device IDK973376
510k NumberK973376
Device Name:LORI/LORI, LORI-S (LORI STOCK AID)
ClassificationHearing Aid, Air Conduction
Applicant LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH Golden Valley,  MN  55427 -4306
ContactJim Hammarstedt
CorrespondentJim Hammarstedt
LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH Golden Valley,  MN  55427 -4306
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-08
Decision Date1997-10-14

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