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510(k) K981260

KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M by Clinical Innovations, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
April 6, 1998
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

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Other clearances for product code HDB

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  • K043614 — VACULINK, MODEL VCL 3000 (April 14, 2005)
  • K021193 — FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (February 12, 2003)
  • K020447 — MITYVAC MERLIN, MODEL 10027 (April 12, 2002)
  • K013460 — SWIFT LOW PROFILE CUP (PRO CUP) (January 17, 2002)
  • K011532 — MITYVAC (July 30, 2001)
  • K980976 — AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP (August 21, 1998)
  • K980212 — MITYVAC (July 9, 1998)
  • K973942 — SWIFT DELIVERY PRODUCT #300 (December 12, 1997)