The following data is part of a premarket notification filed by Stony Brook Surgical Innovations, Inc. with the FDA for Stony Brook Surgical Innovaions Sterna-wire (sternal Sutures).
| Device ID | K013059 |
| 510k Number | K013059 |
| Device Name: | STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | STONY BROOK SURGICAL INNOVATIONS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk STONY BROOK SURGICAL INNOVATIONS, INC. 55 Northern Blvd. Suite 200 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 | 2001-09-11 |
| Decision Date | 2001-10-22 |
| Summary: | summary |