The following data is part of a premarket notification filed by The Healthcare Group Laboratories, Inc. with the FDA for Douche Unit-1500 Ml Disp. Container.
| Device ID | K800957 |
| 510k Number | K800957 |
| Device Name: | DOUCHE UNIT-1500 ML DISP. CONTAINER |
| Classification | Douche Apparatus, Vaginal, Therapeutic |
| Applicant | THE HEALTHCARE GROUP LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HED |
| CFR Regulation Number | 884.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-23 |
| Decision Date | 1980-07-14 |