The following data is part of a premarket notification filed by Groman Inc. with the FDA for Groman Prepmaster.
| Device ID | K030292 |
| 510k Number | K030292 |
| Device Name: | GROMAN PREPMASTER |
| Classification | Airbrush |
| Applicant | GROMAN INC. 1917 NW 80 AVE. Margate, FL 33063 |
| Contact | Barry B Groman |
| Correspondent | Barry B Groman GROMAN INC. 1917 NW 80 AVE. Margate, FL 33063 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-28 |
| Decision Date | 2003-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50817494020170 | K030292 | 000 |
| 40817494020043 | K030292 | 000 |
| 00817494020038 | K030292 | 000 |
| 00817494020021 | K030292 | 000 |
| 40817494020012 | K030292 | 000 |
| 50817494020002 | K030292 | 000 |
| D798EMTRS1 | K030292 | 000 |
| D798EMTLS1 | K030292 | 000 |
| D798EMHAR0 | K030292 | 000 |
| D798EMHA0 | K030292 | 000 |
| D798EMCO20 | K030292 | 000 |
| 10817494020059 | K030292 | 000 |
| 40817494020067 | K030292 | 000 |
| 50817494020163 | K030292 | 000 |
| 30817494020152 | K030292 | 000 |
| 30817494020145 | K030292 | 000 |
| 50817494020132 | K030292 | 000 |
| 30817494020121 | K030292 | 000 |
| 40817494020111 | K030292 | 000 |
| 20817494020100 | K030292 | 000 |
| 40817494020098 | K030292 | 000 |
| 20817494020087 | K030292 | 000 |
| 40817494020074 | K030292 | 000 |
| D798EMHAPR0 | K030292 | 000 |