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510(k) K923534

PM2002 PROLINE by Planmeca USA, Inc. — Product Code KLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1994
Date Received
July 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Dental, With Operative Unit
Device Class
Class I
Regulation Number
872.6250
Review Panel
DE
Submission Type

Other clearances by Planmeca USA, Inc.

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  • K923462 — DELIGHT (December 21, 1992)
  • K923461 — PM2002 PROLINE, PM2002 PROLINE EC (December 21, 1992)
  • K904953 — PLANMED SOPHIE (April 18, 1991)
  • K904948 — PM2002 CC AND PM2002 EC (January 30, 1991)
  • K904947 — PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE (January 30, 1991)
  • K864474 — DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC (November 26, 1986)
  • K842359 — AUTOMATIC PATIENT CHAIR PM2000 & A (September 19, 1984)

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  • K963209 — PROSTYLE COMPACT (October 24, 1996)
  • K942870 — ULTIMA 2 DENTAL CHAIR (February 27, 1995)
  • K940950 — KAVO SYSTEMATICA 1060 (December 29, 1994)
  • K925567 — E 4000 DENTAL OPERATING CHAIR (March 10, 1994)
  • K925119 — A-DEC 1040 CHAIR (January 31, 1994)
  • K925324 — A-DEC 2184 DUO UNIT (December 9, 1993)