The following data is part of a premarket notification filed by Spectrx, Inc. with the FDA for Simplechoice 3.0 Ml Reservoir Pro Reference Number Rp-30.
| Device ID | K051045 |
| 510k Number | K051045 |
| Device Name: | SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 |
| Classification | Pump, Infusion |
| Applicant | SPECTRX, INC. 4955 AVALON RIDGE PARKWAY Norcross, GA 30071 |
| Contact | William M Vondersmith |
| Correspondent | William M Vondersmith SPECTRX, INC. 4955 AVALON RIDGE PARKWAY Norcross, GA 30071 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-25 |
| Decision Date | 2005-08-02 |
| Summary: | summary |