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510(k) K800833

VABRA ASPIRATOR by Cooper Medical Devices Corp. — Product Code HHI

K800833 is an FDA 510(k) premarket notification submitted by Cooper Medical Devices Corp. for the device "VABRA ASPIRATOR". The FDA issued a decision of Substantially Equivalent on May 14, 1980. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Cooper Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1980
Date Received
April 14, 1980
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 Cooper Medical Devices Corp.

  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K802927 — SEBESTYEN IRRIGATING CONTACT LENS (February 5, 1981)
  • K801850 — CHARLES PNEUMATIC INTRAOCULAR SCISSORS (September 16, 1980)
  • K801411 — MAY ILLUMINATED/INFUSION PIC (July 21, 1980)
  • K801312 — THE PROTECTORS (June 17, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)

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