The following data is part of a premarket notification filed by First Industries, Inc. with the FDA for Stopperless Hot/cold Rubber Water Bottle.
| Device ID | K810654 |
| 510k Number | K810654 |
| Device Name: | STOPPERLESS HOT/COLD RUBBER WATER BOTTLE |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FIRST INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-10 |
| Decision Date | 1981-03-27 |