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510(k) K883413

TROJAN EXTRA STRENGTH LUBRICATED by Carter Products — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1988
Date Received
August 15, 1988
Clearance Type
Traditional
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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  • K901202 — TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED (June 19, 1990)
  • K901190 — TROJANS LATEX CONDOMS (MODIFIED LABELING) (April 16, 1990)
  • K901197 — TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL (April 16, 1990)
  • K901191 — TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING) (April 16, 1990)
  • K901198 — TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED (April 16, 1990)

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