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510(k) K840383

MENSTRUAL ASPIRATION KIT by Intl. Medical Technologies, Inc. — Product Code HHI

K840383 is an FDA 510(k) premarket notification submitted by Intl. Medical Technologies, Inc. for the device "MENSTRUAL ASPIRATION KIT". The FDA issued a decision of Substantially Equivalent on April 30, 1984. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Intl. Medical Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1984
Date Received
January 30, 1984
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

Other clearances by Intl. Medical Technologies, Inc.

  • K840381 — TAPERED CERVICAL DILATOR (April 30, 1984)
  • K840384 — DIAGNOSTIC DILATATION & MENSTRUAL KIT (April 30, 1984)
  • K840382 — VACUUM ASPIRATION CATHETER (April 30, 1984)
  • K840380 — UTERINE SOUND (April 30, 1984)

Other clearances for product code HHI

  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)
  • K983181 — CYTOPREP (November 16, 1998)
  • K931205 — MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (March 15, 1994)
  • 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)

FDA data resources