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510(k) K991857

AIRFLOW HANDY by Electro Medical Systems, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1999
Date Received
June 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Electro Medical Systems, Inc.

  • K022328 — EMS PIEZON MASTER 600 (August 13, 2002)
  • K022119 — EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE (July 25, 2002)
  • K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (August 24, 2001)
  • K002484 — EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (October 4, 2000)
  • K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE (July 27, 1999)
  • K965203 — RADX SYSTEM (March 17, 1997)
  • K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER (February 13, 1997)
  • K964111 — LITHOVAC SUCTION/ASPIRATION PROBE (December 16, 1996)
  • K953026 — MINIPIEZON (August 28, 1995)
  • K951531 — SWISS LITHOCLAST LITHOTRIPTER (August 24, 1995)

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