The following data is part of a premarket notification filed by Genzyme Biosurgery with the FDA for Saph-loop Ligating Loop.
| Device ID | K022410 |
| 510k Number | K022410 |
| Device Name: | SAPH-LOOP LIGATING LOOP |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Karen K Sylvia |
| Correspondent | Karen K Sylvia GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-24 |
| Decision Date | 2002-08-20 |
| Summary: | summary |