The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Acromed Double Sublaminar Wire.
| Device ID | K895413 |
| 510k Number | K895413 |
| Device Name: | ACROMED DOUBLE SUBLAMINAR WIRE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Rosemary H Zang |
| Correspondent | Rosemary H Zang ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-05 |
| Decision Date | 1989-11-22 |