510(k) K923457

SHOWERFLOSS by Summit Marketing Group, Inc. — Product Code EFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1992
Date Received
July 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Oral Irrigation
Device Class
Class I
Regulation Number
872.6510
Review Panel
DE
Submission Type