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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Actuator, Syringe, Injector Type
510(k) Number K920177
Device Name VERSA-VIAL
Applicant
Bioteque America, Inc.
51 Rainlily Rd.
Levittown,  PA  19056
Applicant Contact DENIS DORSEY
Correspondent
Bioteque America, Inc.
51 Rainlily Rd.
Levittown,  PA  19056
Correspondent Contact DENIS DORSEY
Regulation Number870.1670
Classification Product Code
DQF  
Date Received01/14/1992
Decision Date 07/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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