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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 K913769
Device Name SYREX SYRINGE
Applicant
Special Machinery Co.
21 Hale Rd., Unit 17
Brampton, Ont
Canada L6w 3j9,  CA
Applicant Contact STAN JANUS
Correspondent
Special Machinery Co.
21 Hale Rd., Unit 17
Brampton, Ont
Canada L6w 3j9,  CA
Correspondent Contact STAN JANUS
Regulation Number872.6770
Classification Product Code
EJI  
Date Received08/22/1991
Decision Date 01/23/1992
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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