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 |