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510(k) K863627

MICRO SURGICAL DRILL SYSTEM by Acumed Instruments Corp.

K863627 is an FDA 510(k) premarket notification submitted by Acumed Instruments Corp. for the device "MICRO SURGICAL DRILL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 2, 1986. Acumed Instruments Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1986
Date Received
September 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Acumed Instruments Corp.

  • K853660 — MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K853659 — POWERED IRRIGATION FOR MICRO SURGICAL DRILL (September 24, 1985)
  • K853658 — BURS FOR MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K791891 — ACU-MED RED MISER HEMOTHORAX BLOOD COLL. (December 5, 1979)
  • K791399 — ACU-ALERT (October 11, 1979)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K790901 — I.V. TUBING ORGANIZER (June 27, 1979)

FDA data resources