510(k) K950754

MACRO SUCTION TUBE MODEL NO 10061 by Dlp, Inc. — Product Code GCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1995
Date Received
February 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type