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510(k) K020512

MTI ST#1 SILICONE PESSARY by Medical Technology and Innovations, Inc. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2002
Date Received
February 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

Other clearances by Medical Technology and Innovations, Inc.

  • K934880 — MTI PHOTOSCREENER (April 6, 1994)
  • K854354 — THE BLEDSOE PASSIVE MOTION EXERCISER (February 6, 1986)

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