The following data is part of a premarket notification filed by Advanced Surgical, Inc. with the FDA for Laparoscopic Cholangiography Catheter Kit.
Device ID | K930787 |
510k Number | K930787 |
Device Name: | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
Contact | Angelique Anderson |
Correspondent | Angelique Anderson ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-16 |
Decision Date | 1993-07-09 |