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510(k) K914035

MINI-MILL by Biomedical Composites, Ltd. — Product Code EMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
September 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Bone, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Biomedical Composites, Ltd.

  • K871312 — FIBREFLEX (April 15, 1987)

Other clearances for product code EMI

  • K912989 — PLANUSTAR AND DENS NOBILIS DENTURE TEETH (August 16, 1991)
  • K851716 — 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES (June 11, 1985)
  • K823676 — DISC NEEDLE SET #TX-8220 (January 9, 1983)