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FDA 510(k), K970788, PNEUMO-MATIC INSUFFLATION NEEDLE
FDA 510(k), K970788, PNEUMO-MATIC INSUFFLATION NEEDLE
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510(K) Number: K970788
Device Name: PNEUMO-MATIC INSUFFLATION NEEDLE
Manufacturer: APPLE MEDICAL CORP.
Device Classification Name: pneumoperitoneum needle
Regulation Number: 876.1500
Classification Product Code: FHO
Date Received: 03/04/1997
Decision Date: 03/27/1997
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PNEUMO-MATIC INSUFFLATION NEEDLE
Manufacturer: APPLE MEDICAL CORP.
Device Classification Name: pneumoperitoneum needle
Regulation Number: 876.1500
Classification Product Code: FHO
Date Received: 03/04/1997
Decision Date: 03/27/1997
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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