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510(k) K030116

ENHANCE-S PLUS H by Conception Technology, Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2003
Date Received
January 13, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by Conception Technology, Inc.

  • K030117 — ENHANCE SPERM FREEZE (March 20, 2003)
  • K991322 — ENHANCE-S PLUS (July 26, 1999)
  • K991104 — MICROTOOLS (July 19, 1999)
  • K973860 — OVULON MONITOR (January 7, 1998)

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  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
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  • K241833 — V-GRAD (March 21, 2025)
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