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510(k) K840384

DIAGNOSTIC DILATATION & MENSTRUAL KIT by Intl. Medical Technologies, Inc. — Product Code HHI

K840384 is an FDA 510(k) premarket notification submitted by Intl. Medical Technologies, Inc. for the device "DIAGNOSTIC DILATATION & MENSTRUAL KIT". The FDA issued a decision of Substantially Equivalent on Apr 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 4 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 30, 1984
Date Received
Jan 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
510(k)

Other clearances by Intl. Medical Technologies, Inc.

  • K840383 — MENSTRUAL ASPIRATION KIT (Apr 30, 1984)
  • K840381 — TAPERED CERVICAL DILATOR (Apr 30, 1984)
  • K840382 — VACUUM ASPIRATION CATHETER (Apr 30, 1984)
  • K840380 — UTERINE SOUND (Apr 30, 1984)

Other clearances for product code HHI

  • K171440 — Berkeley VC-10 Vacuum Curettage System (Sep 29, 2017)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (Jun 23, 2003)
  • K983181 — CYTOPREP (Nov 16, 1998)
  • K931205 — MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (Mar 15, 1994)
  • K904160 — CYTOSMEAR BRUSH (Nov 2, 1990)
  • K900641 — CANNULA, SUCTION UTERINE (Mar 30, 1990)
  • K900642 — SWIVEL ADAPTER (Mar 19, 1990)
  • K880734 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (Apr 25, 1988)
  • K873552 — CANNULA AND GENERAL PURPOSE ASPIRATOR (Nov 25, 1987)
  • K870574 — COSMEDTECH GENERAL ASPIRATOR (Mar 5, 1987)

FDA data resources

Source: FDA 510(k) database entry for K840384. Report a data issue: hello@regdatalab.com.