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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K802008
Device Name BREAKING CAST WIRE CAT.#1112-1115
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
Date Received08/20/1980
Decision Date 09/09/1980
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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