The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman* External Drainage System Ii (eds-ii).
Device ID | K902257 |
510k Number | K902257 |
Device Name: | CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II) |
Classification | Shunt, Central Nervous System And Components |
Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Contact | Donald A Lincoln |
Correspondent | Donald A Lincoln Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-21 |
Decision Date | 1990-07-19 |