The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Surgimedics, Slp Laparoscopic Cholangiogram Cath.
| Device ID | K903709 |
| 510k Number | K903709 |
| Device Name: | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH |
| Classification | Catheter, Cholangiography |
| Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Contact | Bryan E Lynch |
| Correspondent | Bryan E Lynch LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-16 |
| Decision Date | 1990-10-26 |