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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Irrigation, Sterile
510(k) Number K923941
Device Name IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
Applicant
American Healthcare Corp.
One American Healthcare Plaza
3611 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact RALPH S JARRETT
Correspondent
American Healthcare Corp.
One American Healthcare Plaza
3611 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact RALPH S JARRETT
Regulation Number876.5980
Classification Product Code
EYN  
Date Received08/05/1992
Decision Date 06/17/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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