The following data is part of a premarket notification filed by Pilling Weck, Inc. with the FDA for Visistat Stapler.
| Device ID | K943719 |
| 510k Number | K943719 |
| Device Name: | VISISTAT STAPLER |
| Classification | Staple, Removable (skin) |
| Applicant | PILLING WECK, INC. 1 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Ponzell Royster |
| Correspondent | Ponzell Royster PILLING WECK, INC. 1 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | GDT |
| CFR Regulation Number | 878.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-01 |
| Decision Date | 1994-08-24 |