The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Holter In-line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-flo Connectors; Accu-flo Three Way Connector; Codm.
| Device ID | K102961 |
| 510k Number | K102961 |
| Device Name: | HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM |
| 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 | 2010-10-05 |
| Decision Date | 2011-02-18 |
| Summary: | summary |