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510(k) K760958

SURGICAL OSCILLATING SAW by American Safety Equipment Corp. — Product Code DZH

K760958 is an FDA 510(k) premarket notification submitted by American Safety Equipment Corp. for the device "SURGICAL OSCILLATING SAW". The FDA issued a decision of Substantially Equivalent on November 16, 1976. The device falls under product code DZH (Saw, Bone, Ac-Powered), a Class II device regulated under 21 CFR 872.4120. American Safety Equipment Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1976
Date Received
November 1, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saw, Bone, Ac-Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by American Safety Equipment Corp.

  • K801010 — KIRSCHNER WIRE (May 20, 1980)
  • K771699 — CARA-STAIN MODEL 3000 (September 13, 1977)
  • K760956 — SURGICAL MICRO DRILL (November 19, 1976)
  • K760960 — SURGICAL WIRE DRIVER (November 19, 1976)
  • K760957 — SURGICAL RECIPROCATING SAW (November 15, 1976)
  • K760959 — SURGICAL CHISEL (November 15, 1976)

Other clearances for product code DZH

  • K031793 — DENTATUS OSCIOMAT (November 13, 2003)
  • K935443 — ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS (September 20, 1994)
  • K760957 — SURGICAL RECIPROCATING SAW (November 15, 1976)

FDA data resources