510(k) K880377

NOVO VIVO MODEL #17140 AND #17135 by Genesis Industries, Inc. — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1988
Date Received
January 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type