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510(k) K760959

SURGICAL CHISEL by American Safety Equipment Corp. — Product Code EMM

K760959 is an FDA 510(k) premarket notification submitted by American Safety Equipment Corp. for the device "SURGICAL CHISEL". The FDA issued a decision of Substantially Equivalent on November 15, 1976. The device falls under product code EMM (Chisel, Osteotome, Surgical), a Class I device regulated under 21 CFR 872.4565. American Safety Equipment Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1976
Date Received
November 1, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel, Osteotome, Surgical
Device Class
Class I
Regulation Number
872.4565
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)
  • K760958 — SURGICAL OSCILLATING SAW (November 16, 1976)
  • K760957 — SURGICAL RECIPROCATING SAW (November 15, 1976)

Other clearances for product code EMM

  • K963897 — STERI-OSS SINUS AUGMENTATION KIT (November 6, 1996)
  • K864775 — CHISEL (OSTEOTOME, GOUGE, ETC.) (February 12, 1987)
  • K851714 — 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS (June 11, 1985)

FDA data resources