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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Hearing (Insert)
510(k) Number K020296
Device Name ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
Applicant
APOTHECARY PRODUCTS, INC.
11750 12TH AVE. SOUTH
BURNSVILLE,  MN  55337 -1295
Applicant Contact GREG LARSON
Correspondent
APOTHECARY PRODUCTS, INC.
11750 12TH AVE. SOUTH
BURNSVILLE,  MN  55337 -1295
Correspondent Contact GREG LARSON
Classification Product Code
EWD  
Date Received01/28/2002
Decision Date 06/25/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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