510(k) K842933

CARBOL-FUCHSIN, ZIEHL-NEEDSEN by E K Ind., Inc. — Product Code ICL

K842933 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "CARBOL-FUCHSIN, ZIEHL-NEEDSEN". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code ICL (Carbol Fuchsin), a Class I device regulated under 21 CFR 864.1850. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carbol Fuchsin
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type