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510(k) K161376

DragonFly Surgical Drill System by Grace Medical, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2016
Date Received
May 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by Grace Medical, Inc.

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  • K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, (December 6, 2006)
  • K062672 — GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES (October 24, 2006)
  • K062385 — BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES (September 27, 2006)
  • K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT (August 18, 2006)
  • K060518 — PARTIAL OSSICULAR REPLACEMENT PROSTHESES (June 28, 2006)
  • K991394 — STAPES PROSTHESES (May 18, 1999)
  • K981575 — TYMPANOSTOMY TUBE (July 15, 1998)

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