The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Midmark Surgical Lighting Systems.
Device ID | K930686 |
510k Number | K930686 |
Device Name: | MIDMARK SURGICAL LIGHTING SYSTEMS |
Classification | Light, Surgical, Instrument |
Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Contact | Bradley Seiden |
Correspondent | Bradley Seiden MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Product Code | FSQ |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-10 |
Decision Date | 1993-07-30 |