510(k) K822179

FRENZEL EYEGLASSES & RELATED ITEMS by Kelleher Corp. — Product Code KHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1982
Date Received
July 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Caloric-Air
Device Class
Class I
Regulation Number
874.1800
Review Panel
EN
Submission Type