The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Suction Irrigation Cautery Probe.
| Device ID | K922002 |
| 510k Number | K922002 |
| Device Name: | SUCTION IRRIGATION CAUTERY PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Contact | Drew D Weaver |
| Correspondent | Drew D Weaver MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-29 |
| Decision Date | 1992-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559100657 | K922002 | 000 |
| 30614559100640 | K922002 | 000 |
| 30614559100572 | K922002 | 000 |
| 30614559100565 | K922002 | 000 |
| 30614559100558 | K922002 | 000 |
| 30614559100534 | K922002 | 000 |
| 30614559100527 | K922002 | 000 |
| 30614559105379 | K922002 | 000 |
| 10614559105375 | K922002 | 000 |