The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Universal Electrosurgical Pad, Split (9160) 3m Universal Electrosurgical Pad (9130).
| Device ID | K974553 |
| 510k Number | K974553 |
| Device Name: | 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | 3M HEALTH CARE 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 -1000 |
| Contact | Linda Johnsen |
| Correspondent | Linda Johnsen 3M HEALTH CARE 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 -1000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1998-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387563696 | K974553 | 000 |
| 50707387462562 | K974553 | 000 |