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510(k) K943938

MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE by Neward Enterprises, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
August 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor, Vacuum, Fetal
Device Class
Class II
Regulation Number
884.4340
Review Panel
OB
Submission Type

Other clearances by Neward Enterprises, Inc.

  • K960549 — MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE (August 29, 1996)
  • K934011 — MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE (May 4, 1994)
  • K925572 — MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE (October 8, 1993)
  • K913324 — MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT (June 22, 1992)
  • K910815 — CR SPIRAL ELECTRODE (December 10, 1991)
  • K890307 — MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE (March 31, 1989)
  • K840403 — VENA * BRIDGE (March 12, 1984)

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