The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for Spectrum Ii, Spectrum Plus, And Spectrum Max-sd.
| Device ID | K965187 |
| 510k Number | K965187 |
| Device Name: | SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SPARTA SURGICAL CORP. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Thomas J Bouchard |
| Correspondent | Thomas J Bouchard SPARTA SURGICAL CORP. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-24 |
| Decision Date | 1997-08-01 |