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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 K992091
Device Name PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
Applicant
Bio-Plexus, Inc.
129 Reservoir Rd.
Vernon,  CT  06066
Applicant Contact PAUL A TENTHOREY
Correspondent
Bio-Plexus, Inc.
129 Reservoir Rd.
Vernon,  CT  06066
Correspondent Contact PAUL A TENTHOREY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/21/1999
Decision Date 09/09/1999
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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