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510(k) K853947

OMNI-TRACT CHEST WALL & LUNA RETRACTOR by Minnesota Scientific, Inc. — Product Code GAD

K853947 is an FDA 510(k) premarket notification submitted by Minnesota Scientific, Inc. for the device "OMNI-TRACT CHEST WALL & LUNA RETRACTOR". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Minnesota Scientific, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
September 24, 1985
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 Minnesota Scientific, Inc.

  • K872919 — OMNI-TRACT CORRAL RETRACTOR (August 11, 1987)
  • K853948 — MINNESOTA SCIENTIFIC, INC. OMNI-BEAM (October 16, 1985)
  • K842762 — OMNI-TRACT SURGICAL RETRACTOR SYS (August 17, 1984)
  • K810282 — OPERATING TABLE ACCESSORY CLAMP (February 26, 1981)

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