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510(k) K871069

MODIFIED HYSTEROSALPINGOGRAPY SET by Ackrad Laboratories — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1987
Date Received
March 18, 1987
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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  • K915813 — ACKRAD ERCP CONTRAST DELIVERY SET (March 11, 1992)
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