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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Surgical, General Use
510(k) Number K892521
Device Name CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE
Applicant
Cymed, Inc.
3447 Investment Blvd.
Hayward,  CA  94545
Applicant Contact DONALD A DEROECK
Correspondent
Cymed, Inc.
3447 Investment Blvd.
Hayward,  CA  94545
Correspondent Contact DONALD A DEROECK
Regulation Number878.4800
Classification Product Code
FZS  
Date Received04/11/1989
Decision Date 05/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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