The following data is part of a premarket notification filed by 3m Company with the FDA for Em 1149 Optimize Scotchplate Conduc Adhes Disp Ele.
| Device ID | K900332 |
| 510k Number | K900332 |
| Device Name: | EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Contact | Julia Wannamaker |
| Correspondent | Julia Wannamaker 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387563498 | K900332 | 000 |