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 |