The following data is part of a premarket notification filed by Northeast Scientific, Inc. with the FDA for Nes Reprocessed Endoscopic Trocar.
Device ID | K060676 |
510k Number | K060676 |
Device Name: | NES REPROCESSED ENDOSCOPIC TROCAR |
Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
Applicant | Northeast Scientific, Inc. 29 SOUTH COMMONS ROAD Waterbury, CT 06704 |
Contact | Craig Allmendinger |
Correspondent | Craig Allmendinger Northeast Scientific, Inc. 29 SOUTH COMMONS ROAD Waterbury, CT 06704 |
Product Code | NLM |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-14 |
Decision Date | 2007-09-07 |
Summary: | summary |