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510(k) K001212

TROJAN EXTRA LARGE LATEX CONDOM by Armkel, LLC — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2000
Date Received
April 14, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM (March 3, 1997)

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