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510(k) K935443

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS by Osada Electric Co., Ltd. — Product Code DZH

K935443 is an FDA 510(k) premarket notification submitted by Osada Electric Co., Ltd. for the device "ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS". The FDA issued a decision of Substantially Equivalent on September 20, 1994. The device falls under product code DZH (Saw, Bone, Ac-Powered), a Class II device regulated under 21 CFR 872.4120. Osada Electric Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1994
Date Received
November 12, 1993
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 Osada Electric Co., Ltd.

  • K904742 — OSADA ENDEX (December 17, 1990)
  • K844250 — OSADA ENAC (January 23, 1985)

Other clearances for product code DZH

  • K031793 — DENTATUS OSCIOMAT (November 13, 2003)
  • K760958 — SURGICAL OSCILLATING SAW (November 16, 1976)
  • K760957 — SURGICAL RECIPROCATING SAW (November 15, 1976)

FDA data resources