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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K780900
Device Name SLICK SET
Applicant
Polamedco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Polamedco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/15/1978
Decision Date 07/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
Recalls CDRH Recalls
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