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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Jet, Mechanical-Powered
510(k) Number K864294
Device Name HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
Applicant
Smith & Nephew, Inc.
1820 W. Roscoe St.
Chicago,  IL  60657
Applicant Contact THOMAS F WILLER
Correspondent
Smith & Nephew, Inc.
1820 W. Roscoe St.
Chicago,  IL  60657
Correspondent Contact THOMAS F WILLER
Regulation Number872.4475
Classification Product Code
EGM  
Date Received10/31/1986
Decision Date 11/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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