The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Custom Instrument Drape.
| Device ID | K843890 |
| 510k Number | K843890 |
| Device Name: | CUSTOM INSTRUMENT DRAPE |
| Classification | Drape, Microscope, Ophthalmic |
| Applicant | LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland, TX 77478 |
| Contact | Rick Wilborn |
| Correspondent | Rick Wilborn LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland, TX 77478 |
| Product Code | HMW |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-02 |
| Decision Date | 1984-10-26 |