The following data is part of a premarket notification filed by Internacional Farmaceutica, S.a. De C.v. with the FDA for Sterile Stainless Steel Monofil Nonabsorb Surg Sut.
| Device ID | K913185 |
| 510k Number | K913185 |
| Device Name: | STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| 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 | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-18 |
| Decision Date | 1991-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07500142180682 | K913185 | 000 |
| 07500142180552 | K913185 | 000 |
| 07500142147364 | K913185 | 000 |
| 07500142147357 | K913185 | 000 |