The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Phosphate Buffered Saline (1x).
| Device ID | K811791 |
| 510k Number | K811791 |
| Device Name: | PHOSPHATE BUFFERED SALINE (1X) |
| Classification | Ph Buffer |
| Applicant | DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCC |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-24 |
| Decision Date | 1981-08-25 |