510(k) K822038

VOLU-SOL ORANGE G-6(GILLS-MOD by Volu Sol Medical Industries — Product Code HZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1982
Date Received
July 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orange G
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type