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510(k) K881609

SITZMARKS by Lafayette Pharmacal, Inc. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
April 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

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