The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Electrically Controlled I.v. Pole (opthalmic).
| Device ID | K861013 |
| 510k Number | K861013 |
| Device Name: | ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | AMERITEK, INC. 9805 S.W. 132nd Court Miami, FL 33186 |
| Contact | Robert Galan |
| Correspondent | Robert Galan AMERITEK, INC. 9805 S.W. 132nd Court Miami, FL 33186 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-03-31 |