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510(k) K852014

EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA by Effner and Spreine Co. — Product Code KOA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1985
Date Received
May 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Effner and Spreine Co.

  • K875260 — EFFNER CAUTERY INSTRUMENTS (June 6, 1988)
  • K874755 — EFFNER FE-EX* OROGASTRIC (April 6, 1988)
  • K872480 — KAHN-TACT U.S.A., EFF LARYNGOSCOPE (August 10, 1987)

Other clearances for product code KOA

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  • K950267 — URETHRAL SUTURE GUIDE (January 31, 1995)
  • K932465 — LI VASECTOMY (March 2, 1994)
  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (October 5, 1992)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)