The following data is part of a premarket notification filed by Mdt Biologic Co. with the FDA for Ac Powered And Battery Powered Medical Exam. Light.
| Device ID | K910942 |
| 510k Number | K910942 |
| Device Name: | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT |
| Classification | Light, Surgical, Floor Standing |
| Applicant | MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 |
| Contact | Mark N Smith |
| Correspondent | Mark N Smith MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-06-11 |