510(k) K810098

FOX EYE SHIELDS by American Hospital Supply Corp. — Product Code HOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1981
Date Received
January 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device Class
Class I
Regulation Number
886.4750
Review Panel
OP
Submission Type