The following data is part of a premarket notification filed by Gamut Ent. with the FDA for Jedmed/polack Keratoscope Hs/sl.
| Device ID | K882618 |
| 510k Number | K882618 |
| Device Name: | JEDMED/POLACK KERATOSCOPE HS/SL |
| Classification | Keratoscope, Battery-powered |
| Applicant | GAMUT ENT. 2121 FOUNTAIN DRIVE SUITE N Snellville, GA 30078 -2900 |
| Contact | Bob Hewlett |
| Correspondent | Bob Hewlett GAMUT ENT. 2121 FOUNTAIN DRIVE SUITE N Snellville, GA 30078 -2900 |
| Product Code | HLR |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-24 |
| Decision Date | 1988-07-13 |