The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Hand Activate Sealer/divider.
Device ID | K111600 |
510k Number | K111600 |
Device Name: | REPROCESSED HAND ACTIVATE SEALER/DIVIDER |
Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
Contact | Ramona Kulik |
Correspondent | Ramona Kulik ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
Product Code | NUJ |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-08 |
Decision Date | 2011-11-15 |
Summary: | summary |