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 |