The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Claw (5mm/10mm) Atraumatic Grasp/micro Forceps.
Device ID | K911180 |
510k Number | K911180 |
Device Name: | CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS |
Classification | Forceps |
Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
Contact | Samuella D Emrich |
Correspondent | Samuella D Emrich NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
Product Code | HTD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-18 |
Decision Date | 1991-03-29 |