The following data is part of a premarket notification filed by Hysterx, Inc. with the FDA for Micrograsp Monopolar Coagulator, Model Nos 90001-90010.
| Device ID | K992714 |
| 510k Number | K992714 |
| Device Name: | MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HYSTERX, INC. 18732 SAGINAW Irvine, CA 92612 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon HYSTERX, INC. 18732 SAGINAW Irvine, CA 92612 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-12 |
| Decision Date | 1999-10-05 |
| Summary: | summary |