The following data is part of a premarket notification filed by Pilling Weck, Inc. with the FDA for Hemoclip Ecosystem.
| Device ID | K945520 |
| 510k Number | K945520 |
| Device Name: | HEMOCLIP ECOSYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PILLING WECK, INC. ONE WECK DR. P.O. BOX 12600 Research Triangle Park, NC 27709 |
| Contact | Ponzelle Royster |
| Correspondent | Ponzelle Royster PILLING WECK, INC. ONE WECK DR. P.O. BOX 12600 Research Triangle Park, NC 27709 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-10 |
| Decision Date | 1995-01-27 |