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510(k) K974121

LUBRICATED BAGGY TACTYLON CONDOM by Sensicon Corp. — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1998
Date Received
October 31, 1997
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

Other clearances by Sensicon Corp.

  • K971590 — TACTYLON CONDOM (October 7, 1997)

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