The following data is part of a premarket notification filed by Tools For Surgery, Llc with the FDA for Hemorrhage Occluder Pin.
| Device ID | K040109 |
| 510k Number | K040109 |
| Device Name: | HEMORRHAGE OCCLUDER PIN |
| Classification | Staple, Implantable |
| Applicant | TOOLS FOR SURGERY, LLC 1339 STONY BROOK ROAD Stony Brook, NY 11790 |
| Contact | Arnold R Leiboff |
| Correspondent | Arnold R Leiboff TOOLS FOR SURGERY, LLC 1339 STONY BROOK ROAD Stony Brook, NY 11790 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861838000309 | K040109 | 000 |
| 00861838000316 | K040109 | 000 |
| 00840319750056 | K040109 | 000 |
| 00840319750032 | K040109 | 000 |