The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Insulated Hook Scissors/j & L Hook Knives/spatula.
| Device ID | K911316 |
| 510k Number | K911316 |
| Device Name: | INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-26 |
| Decision Date | 1991-04-29 |