The following data is part of a premarket notification filed by Spiess Design, Inc. with the FDA for Hydrodisector.
| Device ID | K914177 |
| 510k Number | K914177 |
| Device Name: | HYDRODISECTOR |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | SPIESS DESIGN, INC. 495 LINDBERG LN. Northbrook, IL 60062 |
| Contact | Joachim Spiess |
| Correspondent | Joachim Spiess SPIESS DESIGN, INC. 495 LINDBERG LN. Northbrook, IL 60062 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-18 |
| Decision Date | 1991-11-29 |