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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K803200
Device Name IRRIGATION SET W/BULB SYRINGE
Applicant
Walpak Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Walpak Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received12/17/1980
Decision Date 01/21/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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