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Okamoto USA, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252622 Male Latex Condom HAHIS2026-05-04 View
510(k) K243584 0.04 ZERO ZERO FOUR Male Latex CondomHIS2025-02-18 View
510(k) K203541 Okamoto 002 Lubricated Polyurethane Male CondomMOL2022-02-25 View
510(k) K192669 Extremely Thin 003, ZERO ZERO THREEHIS2020-07-24 View
510(k) K090259 OKAMOTO ULTRA THINHIS2009-03-31 View
510(k) K952393 OKAMOTO CONDOMHIS1995-08-09 View
510(k) K902804 EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANTHIS1990-08-13 View
510(k) K896339 MODIFIED LABELING ON OKAMOTO HARMONY CONDOMHIS1990-01-10 View
510(k) K884402 EXTRA STRENGTH SKIN LESS SKIN CONDOMHIS1989-03-10 View
510(k) K884401 SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANTHIS1989-01-12 View
510(k) K875111 RUBBER CONTRACEPTIVE, LATEX CONDOMSHIS1988-02-26 View
510(k) K872664 SKINLESS SKIN-HARMONY CONDOMSHIS1987-11-05 View
510(k) K872812 SKINLESS-SKIN, PINK TINT (CONDOM)HIS1987-11-05 View
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