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510(k) K960223

CPR YANKAUER by Custom Pack Reliability — Product Code GCX

K960223 is an FDA 510(k) premarket notification submitted by Custom Pack Reliability for the device "CPR YANKAUER". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Custom Pack Reliability has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Custom Pack Reliability

  • K960205 — CPR TRACHEOTOMY CARE TRAY (August 27, 1996)
  • K960243 — CPR C-SECTION DELIVERY PACK (May 23, 1996)
  • K960239 — CPR D & C TRAY (May 23, 1996)
  • K960216 — CPR SUCTION CATHETER KIT (April 15, 1996)
  • K960211 — CPR TOTAL KNEE PACK (April 12, 1996)
  • K960213 — CPR TOTAL HIP PACK (April 12, 1996)
  • K960206 — CPR DRESSING CHANGE TRAY (April 12, 1996)
  • K960210 — CPR ORTHO HAND PACK (April 12, 1996)
  • K960209 — CPR HEART PACK (April 4, 1996)
  • K960214 — CPR FOLEY CAHTETER KIT (April 1, 1996)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)

FDA data resources