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510(k) K905105

JAIN SUTURE/VESIBAND ORGANIZER by Jain Surgical Equipment, Inc. — Product Code MDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
November 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Jain Surgical Equipment, Inc.

  • K913896 — JAIN BLOOD SHIELD (March 6, 1992)
  • K911077 — JAIN SUTURE PACKAGE COUNTER (May 31, 1991)
  • K911076 — JAIN QUICK COUNT (May 30, 1991)
  • K904536 — JAIN GRAFT ASSIST (November 29, 1990)

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  • K022059 — MICROVASIVE PULMONARY GUIDEWIRE (November 13, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K010184 — CHESS HAND SURGERY SYSTEM (June 22, 2001)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (July 9, 1998)
  • K943968 — TUNNELER (March 1, 1995)