510(k) K844774

EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS by Mecron Medical Products, Inc. — Product Code FCR

K844774 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS". The FDA issued a decision of Substantially Equivalent on April 22, 1985. The device falls under product code FCR (Light Source, Photographic, Fiberoptic), 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
April 22, 1985
Date Received
December 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Photographic, Fiberoptic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type