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510(k) K881981

ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM by Ryder Intl. Corp. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1988
Date Received
May 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K920064 — OPTI-LENS CONTACT LENS CASE (March 4, 1992)
  • K915082 — OPTI-LENS(TM) CONTACT LENS CASE (January 13, 1992)
  • K870278 — CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695 (February 20, 1987)
  • K853727 — KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) (February 7, 1986)
  • K853728 — KESTREL CONTACT LENS STORAGE CASE(NORYL) (December 13, 1985)
  • K853729 — KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) (December 13, 1985)

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