The following data is part of a premarket notification filed by Intelifuse, Inc. with the FDA for Intelifuse, Inc., Warmsystem With Stimulinks.
| Device ID | K060014 |
| 510k Number | K060014 |
| Device Name: | INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS |
| Classification | Staple, Fixation, Bone |
| Applicant | INTELIFUSE, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell INTELIFUSE, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-03 |
| Decision Date | 2006-04-03 |
| Summary: | summary |