The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Propencil Smoke Pencil.
| Device ID | K143103 |
| 510k Number | K143103 |
| Device Name: | PROPENCIL Smoke Pencil |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIO PROTECH, INC. Donghwa Medical Instrument Complex, 151-3 Donghwagongdan-ro, Munmak-eup Wonju-si, KR 220-801 |
| Contact | Terry Kim |
| Correspondent | Kevin Han BIO PROTECH USA, INC. 2601 Walnut Ave Tustin, CA 92780 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817325022457 | K143103 | 000 |
| 20817325021689 | K143103 | 000 |
| 20817325021696 | K143103 | 000 |
| 20817325021702 | K143103 | 000 |
| 20817325021719 | K143103 | 000 |
| 20817325021726 | K143103 | 000 |
| 20817325021733 | K143103 | 000 |
| 20817325021740 | K143103 | 000 |
| 20817325021757 | K143103 | 000 |
| 20817325021764 | K143103 | 000 |
| 20817325021771 | K143103 | 000 |
| 20817325021788 | K143103 | 000 |
| 20817325021795 | K143103 | 000 |
| 20817325021801 | K143103 | 000 |
| 20817325021818 | K143103 | 000 |
| 20817325021825 | K143103 | 000 |
| 20817325022426 | K143103 | 000 |
| 20817325022433 | K143103 | 000 |
| 20817325021672 | K143103 | 000 |