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510(k) K962816

SPERM PREPARATION MEDIA by Genx Intl., Inc. — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1996
Date Received
July 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom, Synthetic
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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  • K070689 — LG SPERM FREEZING (July 3, 2007)
  • K020560 — WORKBENCH BY <GENX> (June 19, 2002)
  • K963031 — GENXCATHETER (October 21, 1996)

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