The following data is part of a premarket notification filed by Anchor Products Co. with the FDA for Anchor Laparoscopic Tissue Retrieval System.
Device ID | K982073 |
510k Number | K982073 |
Device Name: | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ANCHOR PRODUCTS CO. 52 OFFICIAL RD. Addison, IL 60101 |
Contact | Robert H Thrum |
Correspondent | Robert H Thrum ANCHOR PRODUCTS CO. 52 OFFICIAL RD. Addison, IL 60101 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-12 |
Decision Date | 1998-09-22 |