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510(k) K840403

VENA * BRIDGE by Neward Enterprises, Inc.

K840403 is an FDA 510(k) premarket notification submitted by Neward Enterprises, Inc. for the device "VENA * BRIDGE". The FDA issued a decision of Substantially Equivalent on March 12, 1984. Neward Enterprises, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
January 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Neward Enterprises, Inc.

  • K960549 — MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE (August 29, 1996)
  • 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)

FDA data resources