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510(k) K924200

REFLEX(R) ESC by Richard-Allan Medical Ind., Inc. — Product Code KNF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances by Richard-Allan Medical Ind., Inc.

  • K931879 — REFLEX HTR (March 24, 1994)
  • K926297 — REFLEX ESI (October 15, 1993)
  • K924761 — STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD (April 20, 1993)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)
  • K896262 — TITANIUM LIGATING CLIPS (January 2, 1990)
  • K890314 — PROTECTOR (SURGICAL INSTRUMENT) (February 27, 1989)
  • K873309 — REFLEX(TM) CA-T CLIP APPLIER (November 27, 1987)
  • K862404 — REFLEX(TM) CLIP APPLIER (July 23, 1986)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)
  • K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (June 3, 1986)

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