The following data is part of a premarket notification filed by Keisei Medical Industrial Co., Ltd. with the FDA for Keisei Scalpel (sterile And Non-sterile).
| Device ID | K863213 |
| 510k Number | K863213 |
| Device Name: | KEISEI SCALPEL (STERILE AND NON-STERILE) |
| Classification | Scalpel, One-piece |
| Applicant | KEISEI MEDICAL INDUSTRIAL CO., LTD. 9 AUTUMN DR. Bethel, CT 06801 |
| Contact | Deborah A Kuter |
| Correspondent | Deborah A Kuter KEISEI MEDICAL INDUSTRIAL CO., LTD. 9 AUTUMN DR. Bethel, CT 06801 |
| Product Code | GDX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-20 |
| Decision Date | 1986-09-02 |