The following data is part of a premarket notification filed by Helix Medical, Inc. with the FDA for Houts Hysterectomy Drain.
| Device ID | K894220 |
| 510k Number | K894220 |
| Device Name: | HOUTS HYSTERECTOMY DRAIN |
| Classification | Catheter, Peritoneal |
| Applicant | HELIX MEDICAL, INC. 210 SANTA BARBERA ST. Santa Barbera, CA 93101 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel HELIX MEDICAL, INC. 210 SANTA BARBERA ST. Santa Barbera, CA 93101 |
| Product Code | GBW |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-08-24 |