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510(k) K942207

REFLEX INS INSUFFLATION NEEDLE by Richard-Allan Medical — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
May 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

Other clearances by Richard-Allan Medical

  • 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)
  • K924929 — REFLEX(R) ECA (July 21, 1993)
  • K905701 — RICHARD-ALLAN SHEET CLIP (February 19, 1991)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)

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  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
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