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FDA 510(k), K901202, TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
FDA 510(k), K901202, TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
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510(K) Number: K901202
Device Name: TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
Manufacturer: C KOLAKOWSKY
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: KXA
Date Received: 03/12/1990
Decision Date: 06/19/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
Manufacturer: C KOLAKOWSKY
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: KXA
Date Received: 03/12/1990
Decision Date: 06/19/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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