510(k) K844773

EFF-EFFNER BULBS by Mecron Medical Products, Inc. — Product Code FFS

K844773 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "EFF-EFFNER BULBS". The FDA issued a decision of Substantially Equivalent on January 8, 1985. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Mecron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1985
Date Received
December 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image, Illumination, Fiberoptic, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type