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510(k) K924929

REFLEX(R) ECA by Richard-Allan Medical — Product Code HBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Hemostatic Clip
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Richard-Allan Medical

  • K942207 — REFLEX INS INSUFFLATION NEEDLE (May 27, 1994)
  • K935105 — REFLEX ESP WITH FINGER SWITCHES (February 22, 1994)
  • K933508 — REFLEX SDD SURGICAL STAPLER (November 23, 1993)
  • K933901 — REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) (November 19, 1993)
  • K924881 — REFLEX(R) ESP (July 23, 1993)
  • K905701 — RICHARD-ALLAN SHEET CLIP (February 19, 1991)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)

Other clearances for product code HBT

  • K896262 — TITANIUM LIGATING CLIPS (January 2, 1990)
  • K862696 — TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP (July 30, 1986)
  • K800318 — DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI (March 10, 1980)