510(k) K911072

SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR by A & F Products — Product Code EHZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Oral Cavity
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type