The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Pint Bottle Well.
| Device ID | K781364 |
| 510k Number | K781364 |
| Device Name: | PINT BOTTLE WELL |
| Classification | Dispenser, Liquid Medication |
| Applicant | BAXA CORP., SUB. OF COOK GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYX |
| CFR Regulation Number | 880.6430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-07 |
| Decision Date | 1978-10-17 |