The following data is part of a premarket notification filed by Matsutani Seisakusho Co. Ltd. with the FDA for Manipler Disposable Skin Stapler.
| Device ID | K925526 |
| 510k Number | K925526 |
| Device Name: | MANIPLER DISPOSABLE SKIN STAPLER |
| Classification | Staple, Removable (skin) |
| Applicant | MATSUTANI SEISAKUSHO CO. LTD. C/O THE LAHR CONSULTING GROUP ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 |
| Contact | Brenda M Kelly |
| Correspondent | Brenda M Kelly MATSUTANI SEISAKUSHO CO. LTD. C/O THE LAHR CONSULTING GROUP ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 |
| Product Code | GDT |
| CFR Regulation Number | 878.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-06-24 |