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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 K961251
Device Name PUNCTUR-GUARD WINGED SET
Applicant
Bio-Plexus, Inc.
384 Merrow Rd.
Tolland,  CT  06084
Applicant Contact CARL SAHI
Correspondent
Bio-Plexus, Inc.
384 Merrow Rd.
Tolland,  CT  06084
Correspondent Contact CARL SAHI
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/01/1996
Decision Date 06/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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