510(k) K801927

SILENTSLEEP by Slumber Research, Inc. — Product Code DYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1980
Date Received
August 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Saliva Ejector
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type