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510(k) K844173

FEMTEST by Bionexus, Inc. — Product Code HES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1985
Date Received
October 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Device Class
Class II
Regulation Number
884.1300
Review Panel
OB
Submission Type

Other clearances by Bionexus, Inc.

  • K870209 — NEXADENT (DENTAL CEMENT) (February 19, 1987)

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  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
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