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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K843206
Device Name COOK COUNTY HOSPITAL DRESSING CHANGE SET
Applicant
Geneva Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Geneva Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
KDD  
Date Received08/15/1984
Decision Date 05/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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