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510(k) K030935

BERKELEY V-10 VACUUM CURETTAGE SYSTEM by Acmi Corporation — Product Code HHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2003
Date Received
March 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Abortion, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

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Other clearances for product code HHI

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  • K904160 — CYTOSMEAR BRUSH (November 2, 1990)
  • K900641 — CANNULA, SUCTION UTERINE (March 30, 1990)
  • K900642 — SWIVEL ADAPTER (March 19, 1990)
  • K880734 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (April 25, 1988)
  • K873552 — CANNULA AND GENERAL PURPOSE ASPIRATOR (November 25, 1987)
  • K870574 — COSMEDTECH GENERAL ASPIRATOR (March 5, 1987)
  • K870560 — COSMEDTECH CANNULA (March 4, 1987)