The following data is part of a premarket notification filed by Galenica Enterprises, Inc. with the FDA for Disposable External Clamps.
| Device ID | K896383 |
| 510k Number | K896383 |
| Device Name: | DISPOSABLE EXTERNAL CLAMPS |
| Classification | Dissector, Surgical, General & Plastic Surgery |
| Applicant | GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Contact | Betty Mailhot |
| Correspondent | Betty Mailhot GALENICA ENTERPRISES, INC. C.P. 13 STE-THERESE Quebec Canada J7e 4h7, CA |
| Product Code | GDI |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1989-12-06 |