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510(k) K904536

JAIN GRAFT ASSIST by Jain Surgical Equipment, Inc. — Product Code GCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1990
Date Received
October 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retainer, Surgical
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)
  • K905105 — JAIN SUTURE/VESIBAND ORGANIZER (January 31, 1991)

Other clearances for product code GCZ

  • 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)
  • K801610 — CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR (August 4, 1980)