The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Denver Peritoneo-venous Shunt.
Device ID | K880401 |
510k Number | K880401 |
Device Name: | DENVER PERITONEO-VENOUS SHUNT |
Classification | Shunt, Peritoneal |
Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Contact | Thomas J Courage |
Correspondent | Thomas J Courage Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Product Code | KPM |
CFR Regulation Number | 876.5955 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-29 |
Decision Date | 1988-05-31 |