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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Absorbent Tipped, Non-Sterile
510(k) Number K820962
Device Name COTTON SWABS
Applicant
Dafoe & Dafoe, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dafoe & Dafoe, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6025
Classification Product Code
KXF  
Date Received04/06/1982
Decision Date 04/20/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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