The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Modular Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors.
Device ID | K991928 |
510k Number | K991928 |
Device Name: | MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Contact | Patricia Sharpe-gregg |
Correspondent | Patricia Sharpe-gregg ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-08 |
Decision Date | 1999-06-25 |
Summary: | summary |