The following data is part of a premarket notification filed by Singer Medical Products, Inc. with the FDA for Axostim.
Device ID | K883807 |
510k Number | K883807 |
Device Name: | AXOSTIM |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
Contact | James I Beck |
Correspondent | James I Beck SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-08 |
Decision Date | 1989-02-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AXOSTIM 73833645 1604479 Dead/Cancelled |
SINGER MEDICAL PRODUCTS, INC. 1989-10-25 |