The following data is part of a premarket notification filed by Medical Products Development, Inc. with the FDA for Surg-flex 5 Surgical Light.
Device ID | K810018 |
510k Number | K810018 |
Device Name: | SURG-FLEX 5 SURGICAL LIGHT |
Classification | Light, Surgical, Instrument |
Applicant | MEDICAL PRODUCTS DEVELOPMENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSQ |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-05 |
Decision Date | 1981-01-23 |