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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K881521
Device Name MODIFIED SERVO SYRINGE
Applicant
Engineering, Inc.
1705 SW 4th St.
Fort Lauderdale,  FL  33312
Applicant Contact KEVIN W SMITH
Correspondent
Engineering, Inc.
1705 SW 4th St.
Fort Lauderdale,  FL  33312
Correspondent Contact KEVIN W SMITH
Regulation Number870.1650
Classification Product Code
DXT  
Date Received04/08/1988
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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