The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Earle's Balanced Salts (ebss) Hybri-max #e9509.
| Device ID | K870486 |
| 510k Number | K870486 |
| Device Name: | EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 |
| Classification | Formulations, Balanced Salt Solutions |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | David Bagley |
| Correspondent | David Bagley SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KIP |
| CFR Regulation Number | 864.2875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-03-30 |