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510(k) K894264

KDF-2.3 by Unimar, Inc. — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
June 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

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  • K895659 — HUI MINI-FLEX (December 19, 1989)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K890848 — CERVEX-BRUSH (May 11, 1989)
  • K854415 — ENDOMETRIAL PIPELLE (March 13, 1986)
  • K810291 — STERILE/DISPOSABLE HSG TRAY (March 18, 1981)

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