The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Elec-trocar Device.
| Device ID | K971728 |
| 510k Number | K971728 |
| Device Name: | PIONEER ELEC-TROCAR DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Burns Severson |
| Correspondent | Burns Severson PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-09-19 |
| Summary: | summary |