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FDA 510(k), K040238, SOFTSEAL HSG CATHETER
FDA 510(k), K040238, SOFTSEAL HSG CATHETER
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510(K) Number: K040238
Device Name: SOFTSEAL HSG CATHETER
Manufacturer: AL MUZZAMMEL
Device Classification Name: Cannula, Manipulator/Injector, Uterine
Regulation Number: LKF
Classification Product Code: KXA
Date Received: 01/26/2004
Decision Date: 06/22/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SOFTSEAL HSG CATHETER
Manufacturer: AL MUZZAMMEL
Device Classification Name: Cannula, Manipulator/Injector, Uterine
Regulation Number: LKF
Classification Product Code: KXA
Date Received: 01/26/2004
Decision Date: 06/22/2004
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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