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510(k) K955672

TROJAN POLYURETHANE CONDOM (MODIFICATION) by Carter Products — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
November 1, 1995
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 Carter Products

  • K942697 — TROJAN POLYURETHANE CONDOM (June 22, 1995)
  • K912901 — TROJAN (TM-TBD) CONDOM (February 3, 1992)
  • K904782 — ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST (December 6, 1990)
  • K904273 — MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. (October 31, 1990)
  • K901202 — TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED (June 19, 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)
  • K901194 — TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL (April 16, 1990)
  • K901196 — TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING (April 16, 1990)

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