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510(k) K902000

KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD by Kevtek Medical Products, Inc. — Product Code FZS

K902000 is an FDA 510(k) premarket notification submitted by Kevtek Medical Products, Inc. for the device "KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD". The FDA issued a decision of Substantially Equivalent on August 21, 1990. The device falls under product code FZS (Curette, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Kevtek Medical Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1990
Date Received
May 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Kevtek Medical Products, Inc.

  • K902193 — KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP (March 15, 1991)

Other clearances for product code FZS

  • K932493 — SURGICAL CURETTE (January 7, 1994)
  • K892521 — CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE (May 1, 1989)
  • K891888 — CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER (April 12, 1989)
  • K891334 — ACU-CURETTE (April 11, 1989)
  • K890366 — ADENOID CURETTE (February 3, 1989)
  • K875292 — MICRODISCECTOMY CURETTE SET (January 29, 1988)
  • K871925 — STRAIGHT CUP CURRETTE, 1.7MM (June 1, 1987)
  • K854899 — NOVAK CURETTE (December 24, 1985)
  • K854888 — RANDALL CURETTE (December 24, 1985)
  • K842701 — HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (August 2, 1984)

FDA data resources