The following data is part of a premarket notification filed by Advanced Surgical, Inc. with the FDA for Laparoscopic Surgical Retractor.
Device ID | K933032 |
510k Number | K933032 |
Device Name: | LAPAROSCOPIC SURGICAL RETRACTOR |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-22 |
Decision Date | 1993-09-09 |