The following data is part of a premarket notification filed by Emc Industries with the FDA for Emc Model No. 322870 Endostat.
| Device ID | K941721 |
| 510k Number | K941721 |
| Device Name: | EMC MODEL NO. 322870 ENDOSTAT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EMC INDUSTRIES 1689 MIDDLETON AVE. Los Altos, CA 94024 |
| Contact | Phlip R Hardaker |
| Correspondent | Phlip R Hardaker EMC INDUSTRIES 1689 MIDDLETON AVE. Los Altos, CA 94024 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-07 |
| Decision Date | 1994-07-06 |