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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 K883506
Device Name IRRIGATION KIT
Applicant
L H M Ent., Inc.
165 Sheffield Cir.
Palm Harbor,  FL  33563
Applicant Contact LOUIS H MUELLER
Correspondent
L H M Ent., Inc.
165 Sheffield Cir.
Palm Harbor,  FL  33563
Correspondent Contact LOUIS H MUELLER
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received08/17/1988
Decision Date 12/13/1988
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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