The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Bipolar Coagulation Probe.
| Device ID | K102273 |
| 510k Number | K102273 |
| Device Name: | MERIT BIPOLAR COAGULATION PROBE |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Dan W Lindsay |
| Correspondent | Dan W Lindsay MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-11 |
| Decision Date | 2010-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816765012086 | K102273 | 000 |
| 00816765012079 | K102273 | 000 |
| 00816765012062 | K102273 | 000 |
| 10724995180703 | K102273 | 000 |
| 10724995180697 | K102273 | 000 |
| 10724995180680 | K102273 | 000 |