The following data is part of a premarket notification filed by Stackhouse, Inc. with the FDA for Stackhouse Lens Hood, Model Sa-700/f.
| Device ID | K000605 |
| 510k Number | K000605 |
| Device Name: | STACKHOUSE LENS HOOD, MODEL SA-700/F |
| Classification | Gown, Surgical |
| Applicant | STACKHOUSE, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Tom Gutierrez |
| Correspondent | Tom Gutierrez STACKHOUSE, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-23 |
| Decision Date | 2000-08-17 |