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510(k) K960549

MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE by Neward Enterprises, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
February 8, 1996
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.

  • K943938 — MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE (May 3, 1995)
  • 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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