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FDA 510(k), K861188, SPERM CAPACITATION MEDIUM
FDA 510(k), K861188, SPERM CAPACITATION MEDIUM
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510(K) Number: K861188
Device Name: SPERM CAPACITATION MEDIUM
Manufacturer: NEWMAN ASSOC.
Device Classification Name: Cap, Cervical
Regulation Number: HDR
Classification Product Code: 03/31/1986
Date Received: 01/06/1987
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SPERM CAPACITATION MEDIUM
Manufacturer: NEWMAN ASSOC.
Device Classification Name: Cap, Cervical
Regulation Number: HDR
Classification Product Code: 03/31/1986
Date Received: 01/06/1987
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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