The following data is part of a premarket notification filed by Granite Chemical Co., Inc. with the FDA for Gc-bc-01, Gc-bc-02, Gc-bc-03 Bicarbonate Dry Packs.
| Device ID | K901472 |
| 510k Number | K901472 |
| Device Name: | GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | GRANITE CHEMICAL CO., INC. P.O. BOX 1504 Mount Airy, NC 27030 |
| Contact | J Griswold |
| Correspondent | J Griswold GRANITE CHEMICAL CO., INC. P.O. BOX 1504 Mount Airy, NC 27030 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-28 |
| Decision Date | 1990-07-27 |