The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Cadman Integrated Irrigation Tubing And Bipolar Cord Set, Models 80-1163, 80-1189.
| Device ID | K052449 |
| 510k Number | K052449 |
| Device Name: | CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Joan Q Bartle |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2005-10-17 |
| Summary: | summary |