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510(k) K901195

TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED by Carter Products — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
March 12, 1990
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

Other clearances by Carter Products

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  • 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)
  • 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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