The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery Nerve Stimulator.
Device ID | K880720 |
510k Number | K880720 |
Device Name: | MONTGOMERY NERVE STIMULATOR |
Classification | Stimulator, Nerve |
Applicant | BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
Contact | Stuart K Montgomery |
Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-23 |
Decision Date | 1988-05-20 |