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 |