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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 K884749
Device Name JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE
Applicant
Johnson & Johnson Patient Care, Inc.
New Brunswick,  NJ  08903
Applicant Contact RICHARD J SKALSKI
Correspondent
Johnson & Johnson Patient Care, Inc.
New Brunswick,  NJ  08903
Correspondent Contact RICHARD J SKALSKI
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received11/14/1988
Decision Date 12/15/1988
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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