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510(k) K140780

KEGEL SMART, KEGELSMART PEARL by Regulatory Insight, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
March 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Regulatory Insight, Inc.

  • K112505 — ETHEREA (April 6, 2012)
  • K020094 — EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-6 (March 8, 2002)
  • K020100 — SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHE (March 8, 2002)

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