The following data is part of a premarket notification filed by Holmed Corp. with the FDA for Christoudias Peritoneum Twin Tissue Approximator.
| Device ID | K942597 |
| 510k Number | K942597 |
| Device Name: | CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HOLMED CORP. 40 NORFOLK AVE. South Easton, MA 02375 |
| Contact | Russell Holmes |
| Correspondent | Russell Holmes HOLMED CORP. 40 NORFOLK AVE. South Easton, MA 02375 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1994-08-15 |