510(k) K812342

ZEE EXTRICATION DEVICE by Zee Medical Products Co., Inc. — Product Code IQF

K812342 is an FDA 510(k) premarket notification submitted by Zee Medical Products Co., Inc. for the device "ZEE EXTRICATION DEVICE". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code IQF (Orthosis, Cervical-Thoracic, Rigid), a Class I device regulated under 21 CFR 890.3490. Zee Medical Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
August 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cervical-Thoracic, Rigid
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type