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510(k) K791001

PENLIGHT/SWAB HOLDER by Concept, Inc. — Product Code KYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1979
Date Received
May 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Examination, Medical, Battery Powered
Device Class
Class I
Regulation Number
880.6350
Review Panel
HO
Submission Type

Other clearances by Concept, Inc.

  • K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE (May 1, 1992)
  • K912957 — CONCEPT MICROMILL (October 4, 1991)
  • K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (June 5, 1990)
  • K894929 — STAPLE FIXATION SYSTEM (August 30, 1989)
  • K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) (August 1, 1989)
  • K891109 — PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE (May 8, 1989)
  • K881954 — CONCEPT POWER SYSTEM (November 9, 1988)
  • K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (November 8, 1988)
  • K882121 — C-FLO SUCTION TUBE (June 20, 1988)
  • K880414 — TENDON HARVESTER (March 25, 1988)

Other clearances for product code KYT

  • K920782 — OLYMPIC TRANS-LITE (March 27, 1992)
  • K841589 — C-LITE (May 22, 1984)
  • K841588 — SUN-LITE WHITE SPOT (May 22, 1984)
  • K781228 — PENLIGHTS (September 7, 1978)
  • K760972 — TYCOS DIAGNOSTIC PENLIGHT (January 26, 1977)