The following data is part of a premarket notification filed by Carefusion 2200, Inc. with the FDA for Diamond-flex(r) Graspers.
Device ID | K110257 |
510k Number | K110257 |
Device Name: | DIAMOND-FLEX(R) GRASPERS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
Contact | Jane Weber |
Correspondent | Jane Weber CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-28 |
Decision Date | 2011-05-06 |
Summary: | summary |