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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 K843925
Device Name GILL'S IRRIGATOR/ASPIRATOR NEEDLE
Applicant
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Applicant Contact CARL A ANGLES
Correspondent
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Correspondent Contact CARL A ANGLES
Regulation Number878.4800
Classification Product Code
GAA  
Date Received10/05/1984
Decision Date 11/05/1984
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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