510(k) K822531

MULTIPLE, ENT CABINET #448 by Midmark Corp. — Product Code ETF

K822531 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MULTIPLE, ENT CABINET #448". The FDA issued a decision of Substantially Equivalent on September 28, 1982. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1982
Date Received
August 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
Submission Type