The following data is part of a premarket notification filed by E & M Engineering, Inc. with the FDA for Electrosurgical Pencil.
| Device ID | K936304 |
| 510k Number | K936304 |
| Device Name: | ELECTROSURGICAL PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | E & M ENGINEERING, INC. 2116 DABNEY RD. SUITE A-5 Richmond, VA 23230 |
| Contact | Winny Chow |
| Correspondent | Winny Chow E & M ENGINEERING, INC. 2116 DABNEY RD. SUITE A-5 Richmond, VA 23230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887482180235 | K936304 | 000 |
| 00887482179291 | K936304 | 000 |
| 00887482179277 | K936304 | 000 |
| 00887482179253 | K936304 | 000 |
| 00887482179239 | K936304 | 000 |
| 00887482179192 | K936304 | 000 |
| 00887482179178 | K936304 | 000 |
| 00887482179154 | K936304 | 000 |
| 00887482179130 | K936304 | 000 |
| 00887482179314 | K936304 | 000 |
| 00887482179338 | K936304 | 000 |
| 00887482179499 | K936304 | 000 |
| 00887482179475 | K936304 | 000 |
| 00887482179451 | K936304 | 000 |
| 00887482179437 | K936304 | 000 |
| 00887482179413 | K936304 | 000 |
| 00887482179390 | K936304 | 000 |
| 00887482179376 | K936304 | 000 |
| 00887482179352 | K936304 | 000 |
| 00887482179116 | K936304 | 000 |