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510(k) K863653

SUCTION-OFF by B&B Medical Technologies, Inc. — Product Code HXD

K863653 is an FDA 510(k) premarket notification submitted by B&B Medical Technologies, Inc. for the device "SUCTION-OFF". The FDA issued a decision of Substantially Equivalent on October 7, 1986. The device falls under product code HXD (Clamp), a Class I device regulated under 21 CFR 878.4800. B&B Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1986
Date Received
September 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by B&B Medical Technologies, Inc.

  • K030396 — OMNI~NEB; OMNI~MAX (May 7, 2004)
  • K980407 — HOPE NEBULIZER (May 27, 1998)
  • K960663 — UNIVERSAL BITE BLOCK (May 17, 1996)
  • K945816 — QUICK-LOCK (January 13, 1995)
  • K944324 — SURE-LOCK VENTILATOR TUBING HOLDER (November 4, 1994)
  • K935171 — STABILTRACH (December 2, 1993)
  • K925386 — ADHESIVE E.T. TAPE (April 19, 1993)
  • K923690 — MINI HEART (October 20, 1992)
  • K913015 — HEART NEBULIZER FLOWMETER ADAPTOR (November 20, 1991)
  • K913753 — BODAI NEO2 -SAFE AIRWAY PRESSURE CAP (October 23, 1991)

Other clearances for product code HXD

  • K890371 — INTESTINAL CRUSHING CLAMP (February 3, 1989)
  • K890372 — INTESTINAL CLAMP (February 3, 1989)
  • K890381 — PARAMETRIUM CLAMP (February 3, 1989)
  • K890368 — KIDNEY CLAMP (February 3, 1989)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K872386 — C CLAMP (July 2, 1987)
  • K853538 — CANNULA CLAMP (September 12, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

FDA data resources