The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sterngold Bio-5 (1127210).
| Device ID | K962326 |
| 510k Number | K962326 |
| Device Name: | STERNGOLD BIO-5 (1127210) |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | STERNGOLD/IMPLAMED 13794 N.W. 4TH ST., SUITE 209 Sunrise, FL 33325 |
| Contact | Nicholas J Savarese |
| Correspondent | Nicholas J Savarese STERNGOLD/IMPLAMED 13794 N.W. 4TH ST., SUITE 209 Sunrise, FL 33325 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841549100239 | K962326 | 000 |
| 00841549100093 | K962326 | 000 |