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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K771760
Device Name EXTEMP
Applicant
PHARMACO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHARMACO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GAA  
Date Received09/19/1977
Decision Date 09/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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