The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Tc2000 Power Unit And Accessories.
| Device ID | K930345 |
| 510k Number | K930345 |
| Device Name: | TC2000 POWER UNIT AND ACCESSORIES |
| Classification | System, Thermal Regulating |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Peter J Scott |
| Correspondent | Peter J Scott GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-25 |
| Decision Date | 1993-08-06 |