The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Universal Electrosurgical Pad Split/solid(9130&9160).
Device ID | K971446 |
510k Number | K971446 |
Device Name: | 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160) |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | 3M COMPANY 3M MEDICAL PRODUCTS GROUP 3M CENTER/275-3E-08 St. Paul, MN 55144 -1000 |
Contact | Linda Johnsen |
Correspondent | Linda Johnsen 3M COMPANY 3M MEDICAL PRODUCTS GROUP 3M CENTER/275-3E-08 St. Paul, MN 55144 -1000 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-21 |
Decision Date | 1997-07-18 |
Summary: | summary |