The following data is part of a premarket notification filed by Meddev International Corp. with the FDA for Meddev Multarray Medical Examining Light Modification.
| Device ID | K940284 |
| 510k Number | K940284 |
| Device Name: | MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION |
| Classification | Device, Medical Examination, Ac Powered |
| Applicant | MEDDEV INTERNATIONAL CORP. P.O. BOX 1352 Los Altos, CA 94023 -1352 |
| Contact | John M Blackmore |
| Correspondent | John M Blackmore MEDDEV INTERNATIONAL CORP. P.O. BOX 1352 Los Altos, CA 94023 -1352 |
| Product Code | KZF |
| CFR Regulation Number | 880.6320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-04 |
| Decision Date | 1994-02-28 |