The following data is part of a premarket notification filed by Internacional Farmaceutica, S.a. De C.v. with the FDA for Ifsa Sterile Nlylon Monofil Nonabsor Surg Sutures.
| Device ID | K905286 |
| 510k Number | K905286 |
| Device Name: | IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck, NY 11021 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-26 |
| Decision Date | 1991-02-11 |