The following data is part of a premarket notification filed by Medtek Devices, Inc. with the FDA for Plumepen Integrated Smoke Evacuation Pencil.
| Device ID | K103375 |
| 510k Number | K103375 |
| Device Name: | PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTEK DEVICES, INC. 595 COMMERCE DR. Amherst, NY 14228 |
| Contact | Greg Pepe |
| 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 | 2010-11-16 |
| Decision Date | 2011-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815198012605 | K103375 | 000 |
| 40845854061337 | K103375 | 000 |
| 20884521834610 | K103375 | 000 |
| 30884521194285 | K103375 | 000 |
| 20815198012384 | K103375 | 000 |
| 20815198012391 | K103375 | 000 |
| 30815198012084 | K103375 | 000 |
| 30815198012091 | K103375 | 000 |
| 30815198012107 | K103375 | 000 |
| 30815198012114 | K103375 | 000 |
| 30815198012220 | K103375 | 000 |
| 00815198012236 | K103375 | 000 |
| 20815198012469 | K103375 | 000 |
| 20815198012476 | K103375 | 000 |
| 40845854061313 | K103375 | 000 |