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510(k) K841682

UTERINE INJECTOR 4.0MM by Humi Corp. — Product Code HES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1984
Date Received
April 23, 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 Humi Corp.

  • K841681 — UTERINE MANIPULATOR 4.5MM (April 23, 1984)

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  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K873515 — UTERINE INJECTOR 2MM (September 29, 1987)