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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 K972523
Device Name PUNCTUAL OCCLUDER
Applicant
Odyssey Medical, Inc.
1710 Shelby Oaks Dr.
Suite #21
Memphis,  TN  38134
Applicant Contact RAYMOND G WALLACE
Correspondent
Odyssey Medical, Inc.
1710 Shelby Oaks Dr.
Suite #21
Memphis,  TN  38134
Correspondent Contact RAYMOND G WALLACE
Classification Product Code
LZU  
Date Received07/07/1997
Decision Date 09/09/1997
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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