The following data is part of a premarket notification filed by Solcoor, Inc. with the FDA for Agar 4000 Neuromuscular Stimulator.
| Device ID | K882387 |
| 510k Number | K882387 |
| Device Name: | AGAR 4000 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 | 1989-10-16 |