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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K884620
Device Name ASD SINGLE LUMEN NEEDLE
Applicant
Biosurge, Inc.
919 Westfall Rd., C-105
Rochester,  NY  14618
Applicant Contact LISA JOERGER
Correspondent
Biosurge, Inc.
919 Westfall Rd., C-105
Rochester,  NY  14618
Correspondent Contact LISA JOERGER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/04/1988
Decision Date 11/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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