The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Eds 3 Csf External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738.
Device ID | K061568 |
510k Number | K061568 |
Device Name: | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 |
Classification | Shunt, Central Nervous System And Components |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Jocelyn Raposo |
Correspondent | Jocelyn Raposo Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-06 |
Decision Date | 2006-09-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780518372 | K061568 | 000 |
00382830050579 | K061568 | 000 |
00382830050609 | K061568 | 000 |
00382830050616 | K061568 | 000 |
10886704040903 | K061568 | 000 |
10886704040910 | K061568 | 000 |
10886704040934 | K061568 | 000 |
10886704040941 | K061568 | 000 |
10886704040958 | K061568 | 000 |
20886704040924 | K061568 | 000 |
00382830050562 | K061568 | 000 |