The following data is part of a premarket notification filed by Anchor Products Co. with the FDA for Anchor Laparscopic Tissue Retieval System.
Device ID | K061555 |
510k Number | K061555 |
Device Name: | ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ANCHOR PRODUCTS CO. 52 OFFICIAL RD. Addison, IL 60101 |
Contact | Robert H Thrun |
Correspondent | Robert H Thrun 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 | 2006-06-05 |
Decision Date | 2006-08-31 |
Summary: | summary |