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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Ent
510(k) Number K822754
Device Name EAR/ULCER SYRINGE
Applicant
American Hospital Supply Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Hospital Supply Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.5220
Classification Product Code
KCP  
Date Received09/08/1982
Decision Date 10/04/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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