The following data is part of a premarket notification filed by Emc Industries with the FDA for Emc Model No. Statome 900.
| Device ID | K911353 |
| 510k Number | K911353 |
| Device Name: | EMC MODEL NO. STATOME 900 |
| Classification | Apparatus, Electrosurgical |
| Applicant | EMC INDUSTRIES C/O PHILIP R. HARDAKER & ASSOC 1689 MIDDLETON AVENUE Los Altos, CA 94024 |
| Contact | Philip R Hardaker |
| Correspondent | Philip R Hardaker EMC INDUSTRIES C/O PHILIP R. HARDAKER & ASSOC 1689 MIDDLETON AVENUE Los Altos, CA 94024 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-27 |
| Decision Date | 1991-06-24 |