The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Electrosurgical Unit Cable.
| Device ID | K913514 |
| 510k Number | K913514 |
| Device Name: | ELECTROSURGICAL UNIT CABLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Contact | Fred Terry |
| Correspondent | Fred Terry KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-07 |
| Decision Date | 1991-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841019112080 | K913514 | 000 |
| 04046955186839 | K913514 | 000 |
| 00841019107119 | K913514 | 000 |
| 20841019107120 | K913514 | 000 |
| 20841019107137 | K913514 | 000 |
| 20841019107144 | K913514 | 000 |
| 00841019107157 | K913514 | 000 |
| 00841019107164 | K913514 | 000 |
| 20841019107175 | K913514 | 000 |
| 20841019107182 | K913514 | 000 |
| 00841019107195 | K913514 | 000 |
| 20841019108134 | K913514 | 000 |
| 20841019108318 | K913514 | 000 |
| 20841019109988 | K913514 | 000 |
| 20841019110021 | K913514 | 000 |
| 20841019110199 | K913514 | 000 |
| 20841019111141 | K913514 | 000 |
| 30850048763808 | K913514 | 000 |