The following data is part of a premarket notification filed by Stony Brook Surgical Innovations, Inc. with the FDA for Sternal Band.
| Device ID | K930015 |
| 510k Number | K930015 |
| Device Name: | STERNAL BAND |
| Classification | Cerclage, Fixation |
| Applicant | STONY BROOK SURGICAL INNOVATIONS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Anand Akerkar |
| Correspondent | Anand Akerkar STONY BROOK SURGICAL INNOVATIONS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-04 |
| Decision Date | 1993-05-19 |