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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sponge, Ophthalmic
510(k) Number K897034
Device Name K-SPONGE
Applicant
Katena Products, Inc.
4 Stewart Ct.
Denville,  NJ  07834
Applicant Contact KATE TIEDEMANN
Correspondent
Katena Products, Inc.
4 Stewart Ct.
Denville,  NJ  07834
Correspondent Contact KATE TIEDEMANN
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received12/18/1989
Decision Date 02/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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