The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Disposable Laser Sponge Surgimedics, 902001-000.
| Device ID | K863089 |
| 510k Number | K863089 |
| Device Name: | DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland, TX 77478 |
| Contact | Mike Barbour |
| Correspondent | Mike Barbour LIFESTREAM INT'L, INC. 525 JULIE RIVERS DR. SUITE 100 Sugarland, TX 77478 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-13 |
| Decision Date | 1986-10-14 |