The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for E-z Pen, Reuseable Handswitching Pencil.
| Device ID | K050102 |
| 510k Number | K050102 |
| Device Name: | E-Z PEN, REUSEABLE HANDSWITCHING PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Ronda K Magneson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559102521 | K050102 | 000 |