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510(k) K870897

KODNER ANAL PERIONEAL RETRACTOR by Sur-Med Instruments, Inc. — Product Code FFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1987
Date Received
March 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Sur-Med Instruments, Inc.

  • K903401 — SPECIAL RONGEUR (August 10, 1990)
  • K870978 — T-TUBE INSERTER (March 19, 1987)

Other clearances for product code FFO

  • K993544 — SPACE-OR RETRACTOR (December 22, 1999)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K853119 — URODYN 1000 (October 4, 1985)
  • K852083 — THE KENDALL URINARY OUTPUT MONITOR (September 20, 1985)