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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 K851903
Device Name ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN
Applicant
Astra Pharmaceutical Products, Inc.
50 Otis St.
Westborough,  MA  01581
Applicant Contact BRUCE R MANNING
Correspondent
Astra Pharmaceutical Products, Inc.
50 Otis St.
Westborough,  MA  01581
Correspondent Contact BRUCE R MANNING
Regulation Number872.6770
Classification Product Code
EJI  
Date Received04/30/1985
Decision Date 07/02/1985
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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