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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K021936
Device Name MOIST PUNCTAL PLUG SYSTEM
Applicant
MOIST MEDICAL INC.
2180 WICKERSHAM LN.
GERMANTOWN,  TN  38139
Applicant Contact GEORGE W MURRAY
Correspondent
MOIST MEDICAL INC.
2180 WICKERSHAM LN.
GERMANTOWN,  TN  38139
Correspondent Contact GEORGE W MURRAY
Classification Product Code
LZU  
Date Received06/12/2002
Decision Date 10/16/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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