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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Allergen And Vaccine Delivery Needles
510(k) Number K890360
Device Name GREER DERMAPIK SYSTEM
Applicant
GREER LABORATORIES, INC.
P.O. BOX 800
LENOIR,  NC  28645
Applicant Contact WHITE, JR.
Correspondent
GREER LABORATORIES, INC.
P.O. BOX 800
LENOIR,  NC  28645
Correspondent Contact WHITE, JR.
Regulation Number880.5570
Classification Product Code
SCL  
Date Received01/25/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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