The following data is part of a premarket notification filed by Suncoast Medical Manufacturers, Inc. with the FDA for Surg-a Stat Loop Tip.
| Device ID | K840376 |
| 510k Number | K840376 |
| Device Name: | SURG-A STAT LOOP TIP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SUNCOAST MEDICAL MANUFACTURERS, INC. P.O. BOX 3345 Clearwater , FL 33515 - |
| Contact | David L Johns |
| Correspondent | David L Johns SUNCOAST MEDICAL MANUFACTURERS, INC. P.O. BOX 3345 Clearwater , FL 33515 - |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-27 |
| Decision Date | 1984-10-26 |