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510(k) K771915

MICRO OSCILLATING SAW by American Sterilizer Co. — Product Code HTZ

K771915 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "MICRO OSCILLATING SAW". The FDA issued a decision of Substantially Equivalent on October 21, 1977. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1977
Date Received
October 12, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by American Sterilizer Co.

  • K943288 — AMSCO SQ240 SURGICAL LIGHT (October 17, 1994)
  • K931872 — THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER (February 7, 1994)
  • K922485 — CHEMDI-VHP CHEMICAL INDICATOR (September 29, 1993)
  • K930493 — QUANTUM 3080 SURGICAL TABLE (June 22, 1993)
  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K896674 — AMSCO QUANTUM LIGHT (January 3, 1990)
  • K895164 — EAGLE DS (November 17, 1989)
  • K882660 — GENERAL SURGICAL TABLE AND ACCESSORIES (July 25, 1988)
  • K880198 — GEMINI SURGICAL LIGHT (February 10, 1988)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)

Other clearances for product code HTZ

  • K933933 — CEBOPLANE (April 15, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K853678 — KAMBIN SPINAL INSTRUMENT SET (September 24, 1985)
  • K850527 — ARTHROSCOPY SUCTION BIOPSY PUNCH (March 14, 1985)
  • K850423 — CONCEPT SUCTION SLEEVE (March 14, 1985)
  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K842774 — CODMAN SUCTION PUNCH-PRODUCT CODES (July 27, 1984)
  • K841975 — ROSETTE KNIFE 4MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

FDA data resources