The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Ms401097-17,ms722-k,ms720,ms721,ms722.
| Device ID | K962767 |
| 510k Number | K962767 |
| Device Name: | MS401097-17,MS722-K,MS720,MS721,MS722 |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
| Contact | Jon Gamerdinger |
| Correspondent | Jon Gamerdinger ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1997-07-03 |