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510(k) K893869

GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) by Adept-Med Intl., Inc. — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
May 26, 1989
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 Adept-Med Intl., Inc.

  • K935636 — GRAVESPEC (March 25, 1994)
  • K893871 — GOOTT BALFOUR BLADE (August 3, 1989)
  • K893870 — ADAMS BREAST IMPLANT PROTECTOR (July 14, 1989)
  • K870809 — MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (March 19, 1987)
  • K802806 — VISECERA RETAINER (January 23, 1981)

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  • 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)