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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, Sterile
510(k) Number K802004
Device Name PROFILE SWAB CAT.#5273 & 5274
Applicant
Pollak (Intl.), Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pollak (Intl.), Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6025
Classification Product Code
KXG  
Date Received08/20/1980
Decision Date 09/16/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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