The following data is part of a premarket notification filed by Spec Systems, Inc. with the FDA for Model Uca / Spec System Uca.
| Device ID | K875305 |
| 510k Number | K875305 |
| Device Name: | MODEL UCA / SPEC SYSTEM UCA |
| Classification | Apparatus, Air Handling, Room |
| Applicant | SPEC SYSTEMS, INC. P.O. BOX 644 701 LAKE DRIVE Kernersville, NC 27285 |
| Contact | Lewis D Mitchell |
| Correspondent | Lewis D Mitchell SPEC SYSTEMS, INC. P.O. BOX 644 701 LAKE DRIVE Kernersville, NC 27285 |
| Product Code | FZH |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-01-27 |