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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 K962999
Device Name SAFETY INJECTION SYSTEM
Applicant
Integritech, Inc.
6020 Bayou Rd.
Mobile,  AL  36605
Applicant Contact JERRY A SMITH
Correspondent
Integritech, Inc.
6020 Bayou Rd.
Mobile,  AL  36605
Correspondent Contact JERRY A SMITH
Regulation Number872.6770
Classification Product Code
EJI  
Date Received08/02/1996
Decision Date 01/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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