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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 K770583
Device Name MEDI-PAK LEMON GLYCEOIN SWABS
Applicant
General Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
General Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6025
Classification Product Code
KXF  
Date Received03/28/1977
Decision Date 05/26/1977
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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