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510(k) K953763

GLADIATOR ANTISHOCK PANTS by Jobst Institute, Inc. — Product Code LHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1995
Date Received
August 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trousers, Anti-Shock
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

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  • K934639 — JOBST ATHROMBIC PUMP - SYSTEM 2500 (February 9, 1994)
  • K922681 — CUTINOVA FOAM (August 31, 1992)
  • K921562 — JOBST EXTREMITY PUMP SYSTEM 7500 (June 22, 1992)
  • K920444 — ULTIMATE (April 20, 1992)
  • K912232 — ULCERCARE (August 14, 1991)
  • K911247 — YOURS TRULY ASYMMETRICAL BREAST FORM (March 29, 1991)
  • K905631 — COMPRINET, COMTESSE AND BELLAVAR STOCKINGS (March 7, 1991)

Other clearances for product code LHX

  • K874774 — TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS (February 8, 1988)
  • K841605 — BP TRAUMA AIR PANTS (July 6, 1984)
  • K812564 — ZEE LIFE SUPPORT AIR PANTS (October 23, 1981)