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FDA 510(k), K941258, LATEX CONDOM
FDA 510(k), K941258, LATEX CONDOM
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510(K) Number: K941258
Device Name: LATEX CONDOM
Manufacturer: ASHOK MURKERJEE
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: KXA
Date Received: 03/16/1994
Decision Date: 12/06/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: LATEX CONDOM
Manufacturer: ASHOK MURKERJEE
Device Classification Name: Condom
Regulation Number: HIS
Classification Product Code: KXA
Date Received: 03/16/1994
Decision Date: 12/06/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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