The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Finger Tip Control Pencil.
| Device ID | K771752 |
| 510k Number | K771752 |
| Device Name: | FINGER TIP CONTROL PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-16 |
| Decision Date | 1977-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704399703 | K771752 | 000 |
| 24026704599909 | K771752 | 000 |
| 24026704662139 | K771752 | 000 |