The following data is part of a premarket notification filed by Therapeutic Technologies, Inc. with the FDA for Spectrastim Tm 1000.
| Device ID | K893964 |
| 510k Number | K893964 |
| Device Name: | SPECTRASTIM TM 1000 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | THERAPEUTIC TECHNOLOGIES, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Contact | Howard Holstein |
| Correspondent | Howard Holstein THERAPEUTIC TECHNOLOGIES, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-02 |
| Decision Date | 1989-10-06 |