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510(k) K883283

DISPOSABLE AMNIOTOME by Galenica Enterprises, Inc. — Product Code HGG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1988
Date Received
August 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K841909 — VAGINAL SPECULUM - DISPOSABLE (July 31, 1984)