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510(k) K934970

DUET by Trulife , Ltd. — Product Code GBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1993
Date Received
October 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Adhesive, External
Device Class
Class I
Regulation Number
878.3750
Review Panel
SU
Submission Type

Other clearances for product code GBJ

  • K810282 — OPERATING TABLE ACCESSORY CLAMP (February 26, 1981)
  • K790946 — GORDON IVS INTRAVENOUS STABILIZER (June 5, 1979)
  • K790186 — PROTECTIVSTABILIZER (February 26, 1979)