The following data is part of a premarket notification filed by Solcoor, Inc. with the FDA for Agar 3k Neuromuscular Stimulator.
Device ID | K882386 |
510k Number | K882386 |
Device Name: | AGAR 3K NEUROMUSCULAR STIMULATOR |
Classification | Stimulator, Muscle, Powered |
Applicant | SOLCOOR, INC. 8150 LEESBURG PIKE, STE.700 Vienna, VA 22180 |
Contact | Barbara A Marsden |
Correspondent | Barbara A Marsden SOLCOOR, INC. 8150 LEESBURG PIKE, STE.700 Vienna, VA 22180 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-10 |
Decision Date | 1989-10-18 |