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 |