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510(k) K101141

SEILER COLPOSCOPE, MODELS 935, 955 AND 985 by Seiler Precision Microscopes — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2010
Date Received
April 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

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  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
  • K161871 — EVA (Enhanced Visual Assessment) System (December 19, 2016)
  • K160341 — Colposcope System (September 14, 2016)
  • K160380 — LT-300 HD (May 13, 2016)
  • K151878 — Video Colposcope (December 1, 2015)
  • K143119 — LT-300 Video Colposcope (December 18, 2014)