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510(k) K891589

3MM DISPOSABLE SPECULA by Semantodontics, Inc. — Product Code FXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1989
Date Received
March 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula Accessories
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
Submission Type