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510(k) K853418

SAFTI-BRACELET by Advanced Biosearch Assn. — Product Code KMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1985
Date Received
August 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type

Other clearances by Advanced Biosearch Assn.

  • K905514 — AUTOGENESIS(TM) AUTOMATOR (April 2, 1991)
  • K883888 — CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (December 12, 1988)
  • K854770 — MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM (February 11, 1986)
  • K855030 — CHAMPY BONE PLATES & BONE SCREWS (January 30, 1986)
  • K855031 — MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P (January 21, 1986)
  • K853916 — P.M. HIP-FEMORAL PROSTHESIS (December 27, 1985)
  • K852839 — FREEMAN HIP (October 29, 1985)
  • K852517 — CLS HIP PROSTHESIS (September 18, 1985)
  • K852699 — FREEMAN ACETABULAR CUP (September 5, 1985)
  • K850773 — PM CEMENTLESS SCREW-IN ACETABULAR CUP (May 2, 1985)

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  • K935389 — CONMED VENI-GARD I.V. DRESSING (March 7, 1994)
  • K935252 — K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (February 18, 1994)