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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. S.
Burnsville,  MN  55337
Applicant Contact GREG LARSON
Correspondent
Apothecary Products, Inc.
11750 12th Ave. S.
Burnsville,  MN  55337
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
Predetermined Change
Control Plan Authorized		 No
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