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510(k) K854622

PROPHYLACTIC (CONDOM) by Medelec Intl. Corp. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
November 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Medelec Intl. Corp.

  • K961013 — DISPOSABLE NEEDLE ELECTRODE (December 20, 1996)
  • K935017 — TD50 ELECTROMYOGRAPH (July 28, 1994)
  • K922548 — MEDELEC 2110 AND 2114 EEG (November 3, 1992)
  • K920127 — ELECTROENCEPHALOGRAPH RECORDING SYSTEM (June 10, 1992)
  • K912775 — SAPPHIRE 4ME EMG/EP SYSTEM (November 8, 1991)
  • K865106 — PROPHYLACTIC (CONDOM) MR. JOHNNY (May 20, 1987)
  • K863491 — BLOOD SPECIMEN COLLECTION DEVICES (October 24, 1986)
  • K854562 — CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I (January 9, 1986)
  • K854857 — SCALPEL, ONE-PIECE, DISPOSABLE (December 24, 1985)
  • K854860 — BLADES, SCALPEL CARBON STEET (December 24, 1985)

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