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510(k) K920471

LEVY ARTICULATING RETRACTOR by Lifeguard Medical Products, Inc. — Product Code GAD

K920471 is an FDA 510(k) premarket notification submitted by Lifeguard Medical Products, Inc. for the device "LEVY ARTICULATING RETRACTOR". The FDA issued a decision of Substantially Equivalent on June 23, 1992. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Lifeguard Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1992
Date Received
January 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Lifeguard Medical Products, Inc.

  • K013421 — LIFEGUARD NASAL CPAP MASK AND ACCESSORIES (January 8, 2002)
  • K915296 — MONOPOLAR ELECTRODE (September 3, 1992)
  • K915505 — REGULATOR FLOWMETER (April 22, 1992)
  • K915297 — TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM (February 11, 1992)
  • K915298 — SUCTION/IRRIGATION CANNULA; CATLOG #532.00 (January 23, 1992)
  • K880958 — LIFEGUARD BACTERIAL AND VIRAL FILTER (April 27, 1988)
  • K881087 — LIFEGUARD SINGLE USE MANUAL RESUSCITATORS (April 14, 1988)
  • K880959 — LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY (April 14, 1988)
  • K881086 — LIFEGUARD MOUTH TO MASK RESUSCITATOR (April 14, 1988)
  • K863711 — REGULATOR OXYGEN MECHANICAL (January 27, 1987)

Other clearances for product code GAD

  • K152538 — JRP Wound Spreader (April 13, 2016)
  • K151104 — OTELO LL (January 6, 2016)
  • K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (October 4, 2013)
  • K071775 — DASH (August 7, 2007)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K043602 — QUADRANT RETRACTOR SYSTEM (February 23, 2005)
  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
  • K943875 — VILLALTA RETRACTOR (November 9, 1994)

FDA data resources