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FDA 510(k), K852200, SIMPLASTIC SUPRA PUBIC CATHETER
FDA 510(k), K852200, SIMPLASTIC SUPRA PUBIC CATHETER
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510(K) Number: K852200
Device Name: SIMPLASTIC SUPRA PUBIC CATHETER
Manufacturer: HUNG
Device Classification Name: Catheter, Suprapubic (And Accessories)
Regulation Number: KOB
Classification Product Code: 05/21/1985
Date Received: 08/07/1985
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SIMPLASTIC SUPRA PUBIC CATHETER
Manufacturer: HUNG
Device Classification Name: Catheter, Suprapubic (And Accessories)
Regulation Number: KOB
Classification Product Code: 05/21/1985
Date Received: 08/07/1985
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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