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510(k) K904953

PLANMED SOPHIE by Planmeca USA, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1991
Date Received
November 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Planmeca USA, Inc.

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  • K923533 — ADMARK (March 4, 1993)
  • K923461 — PM2002 PROLINE, PM2002 PROLINE EC (December 21, 1992)
  • K923462 — DELIGHT (December 21, 1992)
  • 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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