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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 K895024
Device Name PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE
Applicant
Bio-Plexus, Inc.
Twin Ponds Centre (Rt. 195)
384q Merrow Rd.
Tolland,  CT  06084
Applicant Contact CARL SAHI
Correspondent
Bio-Plexus, Inc.
Twin Ponds Centre (Rt. 195)
384q Merrow Rd.
Tolland,  CT  06084
Correspondent Contact CARL SAHI
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/08/1989
Decision Date 09/21/1990
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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