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510(k) K990045

BERACLAMP, MODEL BC-1 by Poamax LLC — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1999
Date Received
January 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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