The following data is part of a premarket notification filed by Boehringer Laboratories, Llc with the FDA for Tissue Removal Pouch.
Device ID | K150781 |
510k Number | K150781 |
Device Name: | Tissue Removal Pouch |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | BOEHRINGER LABORATORIES, LLC 300 Thoms Drive Phoenixville, PA 19460 |
Contact | Chris Radl |
Correspondent | Chris Radl BOEHRINGER LABORATORIES, LLC 300 Thoms Drive Phoenixville, PA 19460 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-25 |
Decision Date | 2015-06-19 |
Summary: | summary |