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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K830524
Device Name HENKE JECT PRESSURE SYRINGE
Applicant
Smith & Nephew, Mpl Division
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Smith & Nephew, Mpl Division
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.6770
Classification Product Code
EJI  
Date Received02/17/1983
Decision Date 03/24/1983
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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