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510(k) K891000

MODIFIED EXTERNAL PAD by Instromedix, Inc. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1989
Date Received
February 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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