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510(k) K850312

GYNASPYR VACUUM CURETTAGE UNIT by Roseburg SA — Product Code HHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1985
Date Received
January 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Abortion, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

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